Pharmaceutical Sciences Jobs in Usa

QC Supervisor

Kelly® Science & Clinical is seeking a QC Supervisor for a direct-hire position at a cutting-edge client in Fort Collins, CO. If you’re passionate about bringing the latest scientific discoveries to life and are ready to take the next step in your career, trust The Experts at Hiring Experts.

Location:Ft. Collins, CO (onsite)

Shift: 1st or 2nd

Salary: $100-105,000 + Benefits

Essential Duties & Responsibilities

• Prioritize workload to meet timelines while ensuring on-time delivery of all projects, testing and action items.
• Take ownership of tasks and results from initiation to completion to meet commitments and proactively address outcomes.
• Escalate and communicate items which arise per the timelines specified in the department escalation strategy.
• Execute all business and department goals and initiatives on time.
• Ensure adherence for compliance with all processes and procedures including training completions, QE and CAPA due dates, notebook and logbook audits, archiving, schedules, internal assessments.
• Issue all Certificates of Analysis within 2 business days of last test completion.
• Generate, monitor and report weekly team and analyst KPIs.
• Supervise the testing and release of Tolmar products, cleaning samples, EM, Bioburden, Endotoxin, raw materials, and stability samples.
• Strive to balance workload across all sites and teams to ensure adequate resource allocation.
• Partner with the scheduler to schedule all testing and reviews, review the weekly schedule and ensure company and department targets are met in the shortest possible cycle time.
• Provide assistance, training and leadership for direct reports through utilization of the OTD resources.
• Create, revise and monitor training progress utilizing training matrices for immediate functional areas, and collaborate with team on remediation of training gaps for site training matrix.
• Set and communicate clear expectations for analysts including providing regular feedback and coaching, monitoring progress and fostering employee development to align individual and team performance with organization goals.
• Create and revise developmental plans to help employees grow their skills and advance their careers.
• Monitor and discuss progress of employee’s performance, growth and development in one on ones utilizing the career ladder and KPIs.
• Establish sample priorities for QC scheduler, submit schedule tickets as needed and ensure adherence to ship dates.
• Partner with the investigations team and the scheduler to ensure all actions for QEs are completed in 24 hours, second analyst testing is completed in less than 5 business days and QEs are closed on time (less than 45 business days).
• Support and execute all potential 3-day field alert investigations and actions expeditiously.
• Submit document change requests for all document updates and minimize document revisions for routine updates where possible.
• Ensure all samples logged into the LIMS system are submitted correctly.
• Identify, and complete cost savings initiatives and facilitate continuous improvement.
• Participate in leadership development activities and take an active role during department and company activities.
• Aid in setting procedure and ensure that all operations and functions (including the laboratory) are in full FDA, cGMP compliance and staff is properly trained.
• Utilize senior analysts to assist in training, document updates, laboratory investigations, projects, or advanced technical issues.
• Conduct and coordinate laboratory investigations, and all associated actions.
• Review and approve technical reports, test methods, specifications and procedural documents and ensure overall validity of the analytical results and review stability reports.
• Participate in project teams, company and department meetings, third party audits, and regulatory audits.
• Monitor departmental spending to stay within the established budget.
• Demonstrate leadership aptitude in technical functions and people management.
• Ability to perform designated duties under minimal supervision and support departmental management in all aspects of organizational functions.
• Accountable for maintaining an atmosphere of teamwork, cordiality and respect towards co-workers.
• Accountable for meeting departmental and compliance timelines.
• Participate in required annual hazardous waste training. Hazardous waste involvement may include, but is not limited to, container and tank management and inspections, generation of hazardous waste as a part of production or sampling processes and transfer of hazardous waste between lab procedure area, satellite accumulation and storage. Respond to spills per the Chemical Spill Procedures.
• Participate in the interview and selection process for candidates, as required.
• Perform other duties as required by business demands.

Knowledge, Skills & Abilities

• Possesses a strong sense of purpose and drive to meet deadlines without sacrificing quality.
• Balances the need for speed with a commitment to accuracy and quality, completing tasks thoughtfully and effectively
• Expert knowledge in analytical testing of drug substances and formulations for Chemistry or Microbiology.
• Ability to perform designated duties under minimal supervision and support departmental management in all aspects of organizational functions.
• Proficient with computer systems for sample tracking, laboratory equipment, raw data handling and storage.
• Knowledge in analytical method validation and instrument qualification.
• Thorough knowledge of government regulations of drugs and medical devices as they apply to laboratory work.
• Technical leadership when working on complex problems within a technical scope in which analysis of situations or data requires an in-depth evaluation of various factors.
• Exceptional interpersonal and organizational skills that lead directly to the advancement of others and of the QC department.
• Ability to supervise a team of analytical professionals that is fully compliant with current Good Manufacturing Practices.
• Knowledge of analytical troubleshooting and product investigation.
• Effective oral and written communication.
• Proficient in the use of analytical laboratory instruments such as HPLC, FTIR, GPC, GC, and UV-Vis spectrophotometers, CCIT, Endotoxin, MODA,.
• Ability to prepare, review, conduct and assess analytical method validations, feasibility and suitable for use.
• Ability to coordinate activities to assure customers’ needs are met in terms of sample analysis cycle time.

Education & Experience

• Bachelor’s degree in science, preferably in Chemistry or Biochemistry, or Microbiology.
• 6+ years’ experience in an analytical laboratory environment with at least five years in a pharmaceutical GMP setting.
• Supervisory or team lead experience is preferred.

What Happens Next

Once you apply, you’ll move forward to next steps if your background aligns with the role. If not, no worries — you’ll remain in our network, giving our Science & Clinical recruiting team access to your profile, helping open the door to future opportunities.

Key Responsibilities

• Document Leadership and Authoring:
• Provides medical writing leadership for clinical programs
• Acts as a medical writing subject matter expert and collaborates with the Clinical Science team to deliver on clinical documents including clinical study protocols and protocol-related documents (e.g. informed consent forms), clinical study reports, DSURs, Investigator’s Brochures, IND clinical summaries/overviews, and CTD components (e.g. Module 2 summaries)
• Partners with the regulatory function to ensure timely completion of high-quality regulatory documents including health authority meeting requests, briefing packages, responses to requests for information, and other documents as required for submissions
• Vendor Management: Provides guidance to external writers on prioritization, content and timeline development, and process management to support clinical development and regulatory activities
• Process Improvement:
• Develops medical writing best practices
• Partners with the Quality Assurance team to develop new and update existing Standard Operating Procedures for Medical Writing processes and all clinical documents to ensure compliance with ICH requirements

Position Requirements

• Master’s degree in a life science discipline from an accredited college or university; PharmD or PhD preferred
• Minimum of 8+ years of scientific or medical writing experience at a biotech/ pharmaceutical company or clinical research organization setting
• Expert knowledge of standard clinical regulatory document types and associated regulatory requirements (e.g. ICH guidance, FDA, EMA, Health Canada, Asia-Pacific regulations, etc.)
• Prior writing experience in Clinical Study Protocols, Clinical Study Reports, DSUR, Investigator’s Brochures, IND clinical summaries/overviews, CTD clinical summaries, and partnering with external investigators to support Investigator Initiated Study Trials
• Expert ability of Microsoft Office Suite, Adobe Acrobat, collaborative review management systems (e.g. SharePoint) and documents management (e.g. Veeva RIM)
• Experience in resource planning and management experience of contractors
• Excellent organization skills with a passion for delivering quality results
• Detail-oriented mindset with excellent verbal and written communication skills
• Self-motivated and able to work collaboratively
• Ability to “roll up sleeves” in a start-up environment and a positive can-do attitude
• Must be willing to work onsite at least 4 days a week

At American Packaging Corporation (APC), you'll find the packaging career you've been looking for. With competitive salaries, excellent benefits, 401(k) plans and tuition reimbursement programs, we nurture our employees while advancing and promoting diversity and inclusion. As the leading flexible packaging converter in North America for over a century, APC's longstanding success is fueled from the inside out. We're constantly seeking to improve our internal operations and were named a "Best of the Best" in the Best workplaces in the America's awards for 12 years in a row. It's how and why we engage the best and brightest talent to continue propelling our shared success into the future.

LOCATION: Columbus, WI

SUMMARY: Ensuring the safety and regulatory compliance of food contact packaging materials is a critical business requirement. The Corporate Regulatory Compliance Manager is responsible for developing and maintaining programs that establish our packaging materials are in compliance with regulations in North America, Europe, and other countries our packaging materials are sold in. By applying technical, organizational and project managerial skills, guidance will be provided to Packaging R&D, Sales, Quality, and Manufacturing teams on packaging regulatory matters.

ESSENTIAL DUTIES AND RESPONSIBILITIES include the following, as well as other duties as assigned.

• Own, Develop, and Manage internal processes, governance and systems/databases to efficiently maintain regulatory compliance of packaging materials; both supplier regulatory information and communications to customers.
• Facilitate and implement legal advice into our business regarding food contact material compliance.
• Respond to customer surveys and requests for regulatory information.
• Collaborate with external suppliers to ensure newly developed or revised packaging materials meet regulatory requirements of targeted applications.
• Proactively anticipates potential hurdles and works with sales and technical teams to resolve.
• Keep abreast of key regulatory and consumer developments for packaging materials via workgroups, literature reviews and industry news. Determine business implications, communicate with cross functional stakeholders, and put action plans in place to address.
• Represent APC at conferences and participation in professional association activities including industry workgroups focused on packaging and food safety.
• Provide training and guidance on regulatory requirements for packaging specifications.
• Manage verification testing and maintain requirements to ensure our packaging materials are safe for use as intended.
• Lead the process to ensure that new materials entering our facilities have been evaluated for food safety and that they are safe for their intended use.
• Manage the process for other packaging based regulatory information to include USP, Drug Master File, Sustainable Materials, End of Life Packaging Responsibilities such as EPR and PPWR, and other material certifications.

Organizational Relationships:

• Reports directly to the Director of R&D and Technical Solutions who provides overall strategic direction.
• Manages direct report(s) to ensure objectives are met and the team is responsive to customers and other stakeholders.
• Interacts with Customers, Suppliers, Sales, Purchasing, Technical, Quality, and Manufacturing Departments at each Center of Excellence to ensure materials have been assessed for their intended use, and supports the required customer documentation as needed.
• Responsible for all discussions and communications with legal advice and customers.

Competencies/Abilities:

• Ability to organize large amounts of information.
• Ability to communicate effectively and professionally with suppliers and customers.
• Ability to visibly lead and make decisions in a fast paced environment.
• Ability to create and manage processes in an ambiguous environment.
• Ability to create plans and organizational alignment to resolve issues.
• Ability to understand and interpret government regulations
• Strong interpersonal and influencing skills.
• Flexibility to travel up to 10% of time.

QUALIFICATION REQUIREMENTS: To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

EDUCATION and/or EXPERIENCE

Bachelor's degree (B.S) in Engineering, Quality, Packaging Science / Engineering, Chemical Engineering, Chemistry, Material Science or Food Science. Minimum 3-5 years' experience in regulatory compliance for packaging materials. Minimum 5-10 years' technical experience in food packaging.

LANGUAGE SKILLS

Ability to read, analyze, and interpret general business periodicals, professional journals, technical procedures, or governmental regulations. Ability to write reports, business correspondence, and procedure manuals. Ability to effectively present information and respond to questions from groups of managers, clients, customers, and the general public.

MATHEMATICAL SKILLS

Ability to calculate figures and amounts such as discounts, interest, commissions, proportions, percentages, area, circumference, and volume. Ability to apply concepts of basic algebra and geometry.

REASONING ABILITY

Ability to solve practical problems and deal with a variety of concrete variables in situations where only limited standardization exists. Ability to interpret a variety of instructions furnished in written, oral, diagram, or schedule form.

PHYSICAL DEMANDS

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

While performing the duties of this job, the employee is regularly required to talk or hear. The employee frequently is required to use hands to finger, handle, or feel. The employee is occasionally required to reach with hands and arms. The employee must occasionally lift and/or move up to 10 pounds. Specific vision abilities required by this job include close vision, color vision, depth perception, and ability to adjust focus.

WORK ENVIRONMENT

The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

While performing the duties of this job, the employee is occasionally exposed to moving mechanical parts, fumes or airborne particles, and risk of electrical shock. The noise level in the work environment is usually moderate.

American Packaging Corporation is committed to equal opportunity for all, without regard to race, religion, color, national origin, citizenship, sex, sexual orientation, gender identity, age, veteran status, disability, genetic information, or any other protected characteristic. American Packaging Corporation will make reasonable accommodations for known physical or mental limitations of otherwise qualified employees and applicants with disabilities unless the accommodation would impose an undue hardship on the operation of our business. EOE/AA Disability/Veteran.

If you are interested in applying for an employment opportunity and need special assistance or an accommodation to apply for a posted position, please contact our Human Resources department at:

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Role Title - Quality Control Analyst III, Analytical

Department- QC

Reports to- QC Manager, Analytical

FLSA -Exempt

Salary Range: $80k- $90k

CORE VALUES

Respect ● Passion ● Teamwork ● Integrity ● Honesty ● Commitment ● Collaboration

COMPANY DESCRIPTION

Polaris Pharmaceuticals, Inc., an affiliate of the Polaris Group ( ), is a therapeutic protein drug manufacturer located in Vacaville, California. Polaris has a cGMP facility producing biological study drugs to support all Polaris Group clinical trials at various stages in the USA, Europe, and the Asian-Pacific region.The lead project of the company is now in clinical trials for patients with different types of cancer including mesothelioma, sarcoma, and glioblastoma. Polaris is seeking candidates to help with the production of this protein drug as well as the production of products for our clients and partners.

ROLE SUMMARY

The Quality Control Analyst, under direct or minimal supervision, is responsible for performing biochemical, physical, and chemical evaluations of process development, lot release, and stability samples compliant with cGMP guidelines. The Analyst works independently on assays that he/she has mastered. This position requires willingness to undergo training on more advanced analytical methods and always employs laboratory safety policies. The Analyst will be responsible for the timely completion of assignments. Good record keeping, organizational, written, and verbal communication skills are essential. The analyst must be willing to work overtime as required.

ROLE RESPONSIBILITIES

• Performs, under direct or minimal supervision, biochemical/physical/chemical analyses of test samples under cGMP to meet specified timelines.
• Reviews test data for accuracy, data integrity, system suitability, and conformance against defined criteria/specifications.
• Provides technical support with troubleshooting of test methods, as needed.
• Identify and contribute to OOS/OOE/OOT investigations related to testing performed.
• Initiate and author deviation and laboratory investigations.
• Maintains the laboratory in an inspection-ready state.
• Develops and maintains proficiency in a broad range of trained test methods.
• Train analysts on test methods and procedures.
• Responsible for authoring Change Control records and leading the revision of written procedures as assigned.
• Holds self and others responsible to abide by department and company policies and practices.
• Adheres to cGMP, 21CFR, USP, EP, ICH, and other applicable regulatory requirements.
• Manage reagent and equipment inventory for assigned areas of responsibilities.
• Responsible for sampling and testing of incoming raw materials

SKILLS

• Strong working knowledge of cGMP regulations, including 21CFR 210 & 211, USP, EP, and ICH.
• Ability to follow written instructions and to perform tasks with direct or minimal supervision.
• Works independently as well as in a team environment.
• Familiarity with use of a computer: e.g., Proficient in Windows, Microsoft Word, Excel.
• Good written, verbal, and communication skills.
• Strong documentation skills a must. The analyst must develop skills in the operation and routine maintenance of various analytical instruments and computers.

The analyst must develop the skills necessary to understand the operation of the equipment and gain knowledge of the equipment used for testing and to use these skills in the event of an unexpected result caused by equipment or reagent failure that warrants a laboratory investigation. Experience with Protein analytics, SDS-PAGE, separations technology for HPLC, Chromatography Data Systems (CDS) software such as OpenLab, subvisible particles testing (USP ), and CCIT preferred. The employee must occasionally lift and/or move up to 25 pounds. Specific vision abilities by this job include close vision, depth perception and ability to adjust focus.

QUALIFICATIONS

B. S./B. A. in Science/Related Field (major in biology-biochemistry-chemistry). Minimum of 5 years of relevant laboratory experience is desired.

Job Location:

Sacramento, CA 95834.

About the Job:

Title of the Position: Automation Technician

The Automation Technician ensures reliable operation of sterile pharmaceutical manufacturing systems by installing, maintaining, calibrating, and troubleshooting automation components, process instrumentation, drives, motors, control devices, clean utility systems, and aseptic production equipment. The role supports continuous and compliant operations under cGMP, FDA 21 CFR Part 11, and cleanroom standards.

Responsibilities:

• Install, maintain, calibrate, and troubleshoot sensors and transmitters for pressure, temperature, flow, level, pH, conductivity, and environmental monitoring.
• Support in performing GMP‑compliant calibrations with complete traceability and accurate documentation.
• Install, maintain, and troubleshoot motors, pumps, fans, drives, control devices, and sterile manufacturing equipment.
• Perform conduit bending, cable routing, wire pulling, cable termination, tray installation, and equipment connections in accordance with plant procedures.
• Install and modify control panels, junction boxes, and instrumentation assemblies.
• Diagnose issues in circuits, protection components, sensors, actuators, drives, and automated machines.
• Use diagnostic tools such as multimeters, clamp meters, insulation testers, and calibration instruments.
• Support PLC, HMI, SCADA, BMS, and EMS platforms, including troubleshooting and system checks.
• Conduct loop checks, functional tests, FAT/SAT, commissioning, and support validation activities (IQ/OQ/PQ).
• Maintain and troubleshoot systems for PW, WFI, Clean Steam, CIP/SIP, HVAC/HEPA controls, and aseptic filling/packaging operations.
• Read and interpret P&IDs, wiring diagrams, schematics, ladder logic, and loop drawings.
• Maintain cleanroom support systems, including differential pressure controls, HEPA filtration, and environmental monitoring.
• Ensure compliance with cGMP, cleanroom classification requirements, FDA 21 CFR Part 11, and data integrity principles.
• Perform preventive, corrective, and predictive maintenance.
• Conduct root‑cause analysis and implement CAPA actions.
• Maintain accurate CMMS entries, calibration logs, and audit‑ready documentation.

Working Condition:

• Ability to work rotating, weekend, or extended shifts.
• Exposure to high‑noise areas (PPE provided).
• Frequent work on mezzanine floors, elevated platforms, ladders, and step‑ups.
• Work inside aseptic cleanrooms and controlled environments (ISO 5/7/8) wearing full gowning.
• Exposure to hot, cold, humid, or pressurized utility systems such as PW, WFI, Clean Steam, and HVAC units.
• Occasional work in tight spaces, behind panels, or equipment enclosures.
• Regular use of PPE, including sterile gowning, gloves, and eye protection.
• Ability to lift to 50 lbs and perform hands-on tasks for extended periods.

Qualifications:

Education:

• BE – Mechanical/Chemical from a reputed University

Experience: Minimum 5 to 10 years of professional experience in the field of pharmaceutical or manufacturing industry.

Knowledge, Skills, and Abilities: Functional:

• Strong troubleshooting skills across sensors, transmitters, motors, drives, actuators, control components, automated machinery, and process systems.
• Experience with conduit bending, tray installation, cable pulling, wire routing, cable dressing, and termination.
• Proficiency in installing and modifying panels, junction boxes, and equipment assemblies.
• Skilled in using multimeters, clamp meters, insulation testers, and calibration devices.
• Ability to install, connect, and terminate control wiring and instrument cabling for field devices.
• Understanding of circuits, drives, starters, protection components, actuators, and control system diagnostics.
• Ability to read and interpret P&IDs, schematics, wiring diagrams, ladder logic, and loop documentation.
• Knowledge of GMP requirements, sterile manufacturing, cleanroom practices, aseptic operations, and validation processes.
• Strong documentation discipline, attention to detail, and audit readiness.
• Ability to work efficiently and safely in regulated manufacturing environments.

Behavioral:

• Result oriented
• Innovative thinking
• Time Management, Professional Work Conduct at all times
• Problem-solving ability & High level of self-motivation
• Strong interpersonal relationship skills
• Strong written & verbal communication skills

Requirements:

• Valid driver's license and acceptable driving record
• Legally authorized to be employed in the United States
• Must live or be willing to move to the Sacramento Metropolitan Region (Approx 40 miles' radius)

Benefits:

• Competitive Salary: $80,000 - $90,000
• Yearly bonus eligibility
• Benefits: offers a wide variety of benefits and programs to support health and well-being, including medical, dental, and vision coverage
• Paid time off plan
• 401k savings plan

About the Role

The Chief Scientific Officer - Early Drug Development will formulate and lead the company's global early-stage R&D strategy, establishing the R&D roadmap from target validation to proof-of-concept (POC).

Responsibilities

• Lead the drug chemistry team and the biology team.
• Establish a global R&D layout and talent echelon for innovative drugs of Qilu.
• Plan and make decisions regarding the innovative drug pipeline, including cutting-edge technology fields such as small molecules, large molecules, ADCs, and small nucleic acids.
• Establish strategic partnerships with the global academic community, research institutions, and biotechnology companies to introduce cutting-edge technologies.
• Research on leadership mechanisms and formulate biomarker strategies to provide a solid scientific basis for R&D decisions.

Qualifications

• Possess a doctoral degree in life sciences or a related medical field.
• Over 20 years of research and development experience in multinational pharmaceutical companies or top biotech firms.

Required Skills

• Profound biological knowledge in core disease areas such as oncology, metabolism, autoimmunity, or the central nervous system.
• Deep understanding of emerging therapeutic modalities.
• Complete R&D success experience from the laboratory to the clinic.
• Led and advanced at least five innovative drug projects into the clinical stage and successfully completed POC.
• Outstanding scientific insight and strategic decision-making ability to predict industry trends and transform them into the company's R&D advantages.
• Outstanding leadership with the charisma and influence to inspire, attract, and retain top scientific talents.

Preferred Skills

• Experience in establishing and managing global R&D teams.
• Strong network within the academic and biotechnology communities.

Pay range and compensation package

Competitive salary and comprehensive benefits package commensurate with experience.

首席科学官 - 早期药物研发

工作职责：

• 制定并领导公司全球早期研发战略，确立从靶点验证到POC的概念验证的研发路线图。
• 统领药物化学团队、生物学团队，构建齐鲁创新药物全球研发布局与人才梯队。
• 主导创新药物管线的规划与决策，包括小分子、大分子、ADC、小核酸等前沿技术领域。
• 作为公司科学领域的最高代表，与全球学术界、研究机构及生物技术公司建立战略合作，引进前沿技术。
• 领导机制研究与生物标志物策略的制定，为研发决策提供坚实的科学依据。

任职要求：

• 拥有生命科学或医学相关领域的博士学位，20年以上在跨国药企或顶尖生物技术公司的研发经验。
• 具备深厚的肿瘤、代谢、自身免疫或中枢神经系统等核心疾病领域的生物学知识，并对新兴治疗模式有深刻理解。
• 拥有从实验室到临床的完整研发成功经验，曾主导推进至少5个创新药物项目进入临床阶段并成功完成POC。
• 卓越的科学洞察力与战略决策能力，能够预见行业趋势并转化为公司的研发优势。
• 出色的领导力，具备激发、吸引和保留顶尖科学人才的人格魅力与影响力。
• 具体岗位职级将根据候选人综合资质确定。

Job Title: QA Consultant (GxP)

Location: San Diego, CA (On-site)

Position Type: Contract / Consultant

Department: Quality Assurance

Reports To: Site Quality Head / Director, QA

Hours requirement: 8 to 5; may need to have some flexibility to work earlier/late as needed

About Us

Based in San Diego, our site operates as a clinical-stage biopharmaceutical facility utilizing unique and proprietary genetic engineering platform technologies to create next-generation cell and gene therapies with the capacity to cure. We are passionate about making an impact on patients' lives with the development of our CAR-T therapies in various cancers and gene therapies for rare diseases. Our goal is to deliver potential single-treatment cures for patients in need.

Position Summary

The Quality organization is seeking an experienced QA Consultant (GxP) to join our team in San Diego, CA. In this on-site contracted role, you will lead the enhancement and maintenance of local Quality Systems, with a primary focus on the Quality Management System (QMS), Electronic Data Management System (EDMS), Document Control, and overall Quality Assurance functions.

You will ensure compliance with regulatory requirements while supporting site-specific needs. This role is integral to the overall GxP Quality system, including processes such as Change Control, Deviation, CAPA, Training, and Document Control, as well as tracking and reporting Quality System Metrics. You will collaborate closely with cross-functional GxP partners including QA, QC, Manufacturing, Validation, Supply Chain, Facilities, and Clinical teams.

Key Responsibilities

Support concurrent activities for legacy Quality systems during QMS integration and system migration phases.

Provide QA oversight for approximately 125 updated SOPs and manual/paper-based systems.

Monitor quality metrics and dashboards to reduce overdue records and maintain effective QMS controls.

Operate and support legacy Quality systems during the transition to new platforms.

Oversee and execute Document Control activities for GxP documents, including manufacturing, clinical, and product quality records.

Assist in managing the GxP Training Program and deliver training on Quality System topics (e.g., Annual GMP Training, Change Control, Deviation, CAPA).

Collaborate with Change Control, Deviation, MRB, and CAPA owners to ensure timely completion and compliance of quality records.

Perform operational functions within the ComplianceWire Learning Management System (LMS) and Qualio (EDMS).

Support continuous improvement efforts for events within EDMS and LMS.

Work with document owners to ensure timely periodic review of procedures.

Assist in the creation and revision of SOPs, policies, forms, templates, and reporting tools.

Generate and trend quality metrics, communicating findings to leadership.

Support internal and external audits, including regulatory agency or partner audits, and assist in executing corrective action plans.

Review and approve paper-based quality documentation and electronic quality records.

Promote a culture of quality, teamwork, and accountability with a patient-first mindset.

Align daily activities with department goals and company values.

Ability to lift up to 20 pounds as needed.

Qualifications

Education: Bachelor’s degree in Life Sciences or related discipline (an equivalent combination of education and experience may be considered).

Experience: Minimum of 8 years of experience in a GxP environment (pharmaceutical, biotech, or cell/gene therapy manufacturing preferred).

Technical Skills:

Strong knowledge of Quality Management Systems in a cGxP manufacturing environment.

Proficiency in core Quality systems: Change Control, Deviations, CAPA, Document Control, and Training.

Hands-on experience with Electronic Document Management Systems (EDMS) and Learning Management Systems (LMS) such as ComplianceWire or Qualio.

Advanced proficiency in Microsoft Office Suite (Excel, PowerPoint, Word).

Competencies:

Exceptional written and verbal communication skills.

Strong attention to detail and ability to manage multiple projects simultaneously.

Proven ability to work independently and collaboratively in a fast-paced, dynamic environment.

Experience developing training materials and delivering training to employees.

Demonstrated ability to write and revise SOPs, work instructions, and Quality System documents.

Job Details:

Global Pharmaceutical Company

QA Shop Floor - 3rd Shift

Fort Washington, PA - Onsite

Long Term, Ongoing Contract

Pay rate $25-30/hr

QA Shop Floor - 3rd shift

Must be able to work four 10 hour days, Sun to Wed 9:30pmEST to 8:00AMEST or

Wed to Sat: 9:30pmEST to 8:00AMEST

Responsible for maintaining quality records, assisting with corrective action plans, and supporting quality system improvements. You will collect and organize data, prepare reports, and ensure inspection readiness while addressing routine quality inquiries.

Key Responsibilities

Collaborate with cross-functional teams to implement innovative quality assurance protocols on the shop floor, ensuring seamless production flow and minimal defects.

Utilize data-driven insights to proactively identify potential quality issues and develop creative solutions to enhance product reliability.

Engage in hands-on inspection of products, applying a keen eye for detail to uphold stringent quality standards.

Performs batch records review and cleaning records review to ensure product availability.

Support work orders review and confirm area cleanliness after maintenance interventions.

Performs area walkthroughs to ensure audit readiness at all times.

Contribute to continuous improvement initiatives by suggesting and piloting novel QA methodologies tailored to dynamic manufacturing environments.

Document and communicate quality findings through clear, concise reports that facilitate swift decision-making and process optimization.

Maintain accurate and timely quality records related to product inspections, nonconformance, and project outcomes.

Assist in documenting, monitoring, and following up on corrective and preventive action plans to ensure their effective implementation and closure.

Respond to routine inquiries regarding technology transfer and improvements in manufacturing processes.

Collect, organize, and analyze data to prepare detailed reports for assigned quality processes.

Document and implement improvements to quality systems and standard operating procedures, including maintaining SOPs for interactions with contract manufacturers.

Gather and maintain documentation required for audits and inspections to ensure inspection readiness.

Support special quality projects and contribute to continuous quality improvement initiatives.

Required Qualifications

Bachelor’s degree or equivalent qualification in Engineering, Quality Management, Science or a related field demonstrating foundational technical knowledge.

2 years of practical experience or internships in quality assurance, manufacturing, or related operational environments.

Strong attention to detail and ability to maintain accurate documentation.

Basic understanding of investigations and automation processes.

Ability to collect, organize, and analyze data effectively.

Good communication skills to respond to routine technical inquiries.

Ability to work independently.

Ability to work night shifts and weekends.

Desired Qualifications

Strong analytical mindset with the ability to interpret complex data and translate it into actionable quality improvements.

Excellent communication skills to effectively collaborate with diverse teams and articulate quality concerns innovatively.

Familiarity with quality systems, audits, and inspection readiness.

Proactive learner with a passion for adopting emerging QA technologies and methodologies to drive shop floor excellence.

Proactive approach to supporting special quality projects and continuous improvement.

Senior Analyst, Sales Operations, Basking Ridge, NJ

Who We Are

Aucta Pharmaceuticals is an emerging product development pharmaceutical company.We are on our way to becoming a significant specialty pharmaceutical company in the U.S. marketplace integrating R&D, manufacturing, and commercialization. We focus on improved dosage forms for patients with a therapeutic focus in CNS and select orphan drug disease states.

Aucta successfully launched its first branded product, Motpoly XR, in the epilepsy space with a targeted sales force in March 2024 and an expanded presence of 20 field sale territories and 3 inside sales positions in late 2024. Our objective is to enhance our marketing, managed care, and sales capabilities to support future pipeline products in neurology over the coming years.

Position Description

The Senior Analyst, Sales Operations, is a key member of Aucta’s Commercial Operations team and plays a critical role in enabling sales effectiveness, operational execution, and data-driven decision-making across the organization.

This role serves as the primary point of contact and vendor manager for core Sales Operations platforms, including Veeva CRM, MMIT, and Power BI, and is responsible for managing core quarterly commercial processes such as Incentive Compensation updates, targeting changes, sales force size and structure adjustments, and system governance.

In addition, this position leads the development and maintenance of training materials and delivers training for both field and inside sales and home office teams across Commercial Operations tools and platforms.

This is a highly visible, hands-on role in a fast-growing environment that requires strong analytical skills, operational rigor, comfort working cross-functionally, and the ability to translate complex data and systems into clear, actionable guidance for the business.

The role reports to the Director of Sales Operations.

Primary Responsibilities:

Sales Operations & Vendor Management

• Serve as the primary point of contact and internal owner for Sales Operations tools and vendors, including Veeva CRM, MMIT, Power BI, and related commercial analytics platforms.
• Manage vendor relationships, system enhancements, issue resolution, upgrades, and roadmap discussions to ensure tools meet evolving business needs.
• Partner with IT, Finance, Sales leadership, and external vendors to maintain data integrity, system performance, and compliance.

Commercial Process Management

• Own and manage the quarterly change process for:
• Incentive compensation plan updates and calculations
• Targeting and call plan changes
• Sales force size, structure, and territory adjustments
• Ensure timely, accurate execution of all changes and clear communication with stakeholders.
• Support forecasting, goal setting, and sales performance tracking activities.

Analytics & Reporting

• Utilize advanced Excel, SQL, and Power BI to analyze sales performance, trends, and operational KPIs.
• Build, maintain, and enhance dashboards and reports to support Sales leadership, Commercial Operations, and Executive leadership.
• Partner cross-functionally to translate business questions into data-driven insights.

Training & Enablement

• Develop, maintain, and continuously improve training materials (guides, SOPs, slide decks, job aids) for Sales Operations tools and processes.
• Conduct training sessions for field and inside Sales and home office associates on:
• Veeva CRM functionality and best practices
• MMIT data usage and interpretation
• Power BI dashboards and reporting
• Other Commercial Operations platforms as needed
• Serve as a trusted resource for ongoing user support and best-practice guidance.

Cross-Functional Support

• Collaborate closely with Sales, Marketing, Managed Care, Finance, and leadership to support commercial execution.
• Participate in sales meetings, planning sessions, and plan-of-action meetings as needed.
• Identify opportunities for process improvement, automation, and scalability as the organization grows.

Required Qualifications

• Bachelor’s degree in Business Administration, Finance, Analytics, Information Systems, or a related field.
• 3-5+ years of experience in Sales Operations, Commercial Operations, or analytics roles, preferably within the pharmaceutical or healthcare industry.
• Hands-on experience with Veeva CRM, MMIT, and Power BI strongly preferred.
• Advanced proficiency in Microsoft Excel (including complex formulas and data modeling); SQL experience preferred.
• Strong understanding of sales force structure, targeting, incentive compensation, and CRM processes.
• Demonstrated ability to manage vendors and cross-functional stakeholders.
• Strong communication and training skills, with the ability to explain technical concepts to non-technical audiences.
• Highly organized, detail-oriented, and able to manage multiple priorities in a fast-paced environment.
• Proactive, collaborative team player with a strong sense of ownership and accountability.

Work Location:

This position is based at our Basking Ridge, NJ site. It is an office-based role, requiring presence 5 days a week. The selected candidate must be able to commute to Basking Ridge, NJ

Salary Range

Aucta Pharmaceuticals considers a combination of education, experience, internal equity, and external market data when determining compensation.

• Base Salary: $80,000 – $110,000 (commensurate with experience)
• Bonus Incentive: 10%

Benefits

Aucta offers a competitive benefits package, including:

• Medical, Dental, and Vision Insurance
• 401(k)
• Life Insurance
• Short- and Long-Term Disability
• Paid Time Off (PTO)

Aucta Pharmaceuticals is an Equal Opportunity/Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to sex, gender identity, sexual orientation, race, color, religion, national origin, disability, protected Veteran status, age, or any other characteristic protected by law.

Please refrain from forwarding unsolicited resumes from agencies to Aucta Pharmaceuticals. Aucta is not liable for any fees incurred from the use of resumes from this source. We only compensate agencies with whom we have a formal agreement. For recruitment inquiries, please reach out directly through this post

Applications will be accepted until the position is filled.

Overview

Georgia Tech prides itself on its technological resources, collaborations, high-quality student body, and its commitment to building an outstanding and diverse community of learning, discovery, and creation. We strongly encourage applicants whose values align with our institutional values, as outlined in our Strategic Plan. These values include academic excellence, diversity of thought and experience, inquiry and innovation, collaboration and community, and ethical behavior and stewardship. Georgia Tech has policies to promote a healthy work-life balance and is aware that attracting faculty may require meeting the needs of two careers.

About Georgia Tech

Georgia Tech is a top-ranked public research university situated in the heart of Atlanta, a diverse and vibrant city with numerous economic and cultural strengths. The Institute serves more than 45,000 students through top-ranked undergraduate, graduate, and executive programs in engineering, computing, science, business, design, and liberal arts. Georgia Tech's faculty attracted more than $1.4 billion in research awards this past year in fields ranging from biomedical technology to artificial intelligence, energy, sustainability, semiconductors, neuroscience, and national security. Georgia Tech ranks among the nation's top 20 universities for research and development spending and No. 1 among institutions without a medical school.

Georgia Tech's Mission and Values

Georgia Tech's mission is to develop leaders who advance technology and improve the human condition. The Institute has nine key values that are foundational to everything we do:

Students are our top priority.
We strive for excellence.
We thrive on diversity.
We celebrate collaboration.
We champion innovation.
We safeguard freedom of inquiry and expression.
We nurture the wellbeing of our community.
We act ethically.
We are responsible stewards.

Over the next decade, Georgia Tech will become an example of inclusive innovation, a leading technological research university of unmatched scale, relentlessly committed to serving the public good; breaking new ground in addressing the biggest local, national, and global challenges and opportunities of our time; making technology broadly accessible; and developing exceptional, principled leaders from all backgrounds ready to produce novel ideas and create solutions with real human impact.

About the Wallace H. Coulter Department of Biomedical Engineering at the Georgia Institute of Technology and Emory University

The Wallace H. Coulter Department of Biomedical Engineering at Georgia Tech and Emory University has a student body of 1,200 undergraduates, 425 graduate students, and 80 primary and 73 program faculty. In 2025 US News Graduate Program Rankings placed the department as the #2 ranked department in BME in the United States and our Undergraduate Program as the #2 department in the United States. Since its beginning, the unique partnership between two of the nation's leading public and private entities has been an innovation engine for research and education. Combining the engineering and medical strengths at Georgia Tech and Emory, we are focused on solving some of the toughest problems facing our state, the nation, and the world.

Atlanta, GA

The Wallace H. Coulter Department of Biomedical Engineering at the Georgia Institute of Technology & Emory University invites applications from exceptional senior candidates working in the area of Neuroengineering, broadly defined. The successful candidate will be named the Georgia Research Alliance (GRA) Eminent Scholar in Neuroengineering, an endowed position specific to the Georgia Tech campus. GRA eminent scholars are expected to engage in or contribute to translational and/or economic development efforts in their field. Applicants should have earned a Ph.D. or equivalent degree. Appointment is expected at the rank of full professor with tenure.

The department seeks a visionary scholar-educator and proven leader in high impact and emerging areas of importance to human health and biomedicine. We are specifically interested in the areas of neuroengineering and neuroscience, particularly developing and using approaches in machine learning and AI, with neurotranslational potential. Along with excellent scholarship, candidates are expected to have demonstrated strong leadership in building and leading extramurally funded research programs, noteworthy dedication to innovative teaching and mentoring of diverse undergraduate and graduate student bodies, as well as national and international recognition. Of particular interest are candidates with an established and active record of accomplishment in leading large multi-institution and multi-disciplinary collaborative research efforts and a vision for developing the next generation of neuroengineering tools to facilitate emerging areas such as interactive neurotechnologies, brain computer interfaces, neuroAI, neural control of sensing and moving, the neural bases of decision making and cognitive function, and the neuroscience of neurological or psychiatric disorders.

Georgia Tech prides itself on its technological resources, collaborations, high-quality student body, and its commitment to building an outstanding and diverse community of learning, discovery, and creation. We strongly encourage applicants whose values align with our institutional values, as outlined in our Strategic Plan. These values include academic excellence, diversity of thought and experience, inquiry and innovation, collaboration and community, and ethical behavior and stewardship. Georgia Tech has policies to promote a healthy work-life balance and is aware that attracting faculty may require meeting the needs of two careers

The successful candidate will interact with a vibrant and rapidly growing multi-disciplinary community across Georgia Tech, Emory, and greater Atlanta. Examples include: the Georgia Tech/Emory Neural Engineering Center; the newly-formed GT Institute for Neuroscience, Neurotechnology, and Society (INNS), crosscutting multiple Colleges; the McCamish Parkinson's Disease Innovation Program; researchers and educators spanning various basic science and engineering departments across Emory and Georgia Tech, as well as clinical departments such as the Emory Department of Rehabilitation, Division of Physical Therapy, Neurology, Neurosurgery, and the Emory Brain Health Center.

A PhD in engineering or related field is required by the start of the appointment.

• A PhD in engineering or related field is required by the start of the appointment.
• The ability to teach and mentor a student body
• The ability to promote a welcoming educational/work environment
• The ability to mentor and assist students interested in pursuing graduate education
• The ability to engage students in experiential learning activities and pedagogy that support student success
• The ability to engage in high-impact practices that support deep learning for student success

Applicants should submit 1) a letter of application, 2) curriculum vitae, 3) a statement of research interests, 4) a description of teaching interests, 5) A statement that in two pages or less outlines how the applicant's professional and academic experiences have prepared them to support and apply Georgia Tech's mission and values , and 6) the names and contact information for at least three references. Application materials should be submitted as .PDF files

Applications will be considered beginning January 15, 2026, but the search will continue until the positions are filled.

Requests for information may be directed to .

The University System of Georgia is comprised of our 26 institutions of higher education and learning as well as the System Office. Our USG Statement of Core Values are Integrity, Excellence, Accountability, and Respect. These values serve as the foundation for all that we do as an organization, and each USG community member is responsible for demonstrating and upholding these standards. More details on the USG Statement of Core Values and Code of Conduct are available in USG Board Policy 8.2.18.1.2 and can be found on-line at policymanual/section8/C224/#p8.2.18_personnel_conduct.

Additionally, USG supports Freedom of Expression as stated in Board Policy 6.5 Freedom of Expression and Academic Freedom found on-line at policymanual/section6/C2653.

The Georgia Institute of Technology (Georgia Tech) is an Equal Employment Opportunity Employer. The Institute is committed to maintaining a fair and respectful environment for all. To that end, and in accordance with federal and state law, Board of Regents policy, and Institute policy, Georgia Tech provides equal opportunity to all faculty, staff, students, and all other members of the Georgia Tech community, including applicants for admission and/or employment, contractors, volunteers, and participants in institutional programs, activities, or services. Georgia Tech complies with all applicable laws and regulations governing equal opportunity in the workplace and in educational activities.

Equal opportunity and decisions based on merit are fundamental values of the University System of Georgia ("USG") and Georgia Tech. Georgia Tech prohibits discrimination, including discriminatory harassment, on the basis of an individual's race, ethnicity, ancestry, color, religion, sex (including pregnancy), national origin, age, disability, genetics, or veteran status in its programs, activities, employment, and admissions. Further, Georgia Tech prohibits citizenship status, immigration status, and national origin discrimination in hiring, firing, and recruitment, except where such restrictions are required in order to comply with law, regulation, executive order, or Attorney General directive, or where they are required by Federal, State, or local government contract.

This is not a supervisory position.
This position does not have any financial responsibilities.
This position will not be required to drive.
This role is not considered a position of trust.
This position does not require a purchasing card (P-Card).
This position will not travel
This position does not require security clearance.

Successful candidate must be able to pass a background check. Please visit employment/pre-employment-screening