Keysource Pharmaceuticals Jobs in Usa

SUMMARY

Experienced HR leader needed to oversee full-scope human resources functions within a brand pharmaceutical environment. This role supports organizational growth by managing recruitment, employee relations, compliance, performance processes, and policy development. The position offers strong professional visibility, the chance to influence HR strategy, and growth potential for someone advancing toward higher-level HR leadership.

Must have brand pharmaceutical industry experience.

RESPONSIBILITIES

• Ensure HR policies and procedures stay current, compliant, and aligned with employment regulations.

• Guide staffing strategies, recruitment activity, and talent acquisition processes to support organizational goals.

• Develop, implement, and refresh HR programs and guidelines, ensuring managers and employees are properly trained.

• Oversee end-to-end hiring operations, including role approvals, applicant review, agency coordination, offer processes, onboarding, and progress tracking.

• Partner on safety, environmental, and security program initiatives as needed.

• Support HR budgeting, workforce planning, talent development, and progression planning efforts.

• Manage employee relations matters such as investigations, corrective actions, performance issues, recognition programs, leave situations, and separation activities.

• Maintain updated organizational charts and accurate job profiles across all business units.

• Assist with benefits program administration, evaluation of vendors, and annual plan reviews.

• Participate in internal and external audits to ensure compliance.

• Review compensation and benefit structures to ensure competitiveness and help attract and retain top talent.

QUALIFICATIONS

• Bachelor’s degree in HR or related field, or equivalent progressive HR experience.

• Minimum five years of HR experience with demonstrated leadership responsibilities.

• Required: prior experience in a brand pharmaceutical organization.

• Strong understanding of HR laws, regulations, and industry best practices.

• Clear communication abilities, both written and verbal.

• Strong interpersonal and leadership skills with the ability to collaborate across all levels.

• Sound judgment and analytical skills with the ability to problem-solve effectively.

• Excellent time-management and organizational skills with the ability to manage multiple priorities.

• Proficiency with Microsoft Office and HR information systems.

• Ability to maintain confidentiality and work independently.

BENEFITS

• Hybrid work model with select remote days.

• Opportunity to influence HR strategy in a growing pharmaceutical environment.

• High-level exposure and partnership with senior leadership.

• Clear long-term growth potential within human resources.

Location: On-site in Upstate NY (Relocation from Canada welcome!)

Please note: We are only considering W2 candidates at this time. Applications from third-party vendors or C2C arrangements will not be considered.

ADVENT Engineering is an engineering and consulting firm providing expertise to the pharmaceutical and biotechnology industries. Headquartered near San Francisco, California, and with operations in the Eastern and Western US, Canada and Singapore, our company is involved in almost every facet of global pharmaceutical and biotechnology facility design and process engineering and quality system projects.

ADVENT's services include process engineering, automation engineering, project engineering, facility/system design, start up and commissioning, validation and compliance consulting for distinguished and successful biotechnology and pharmaceutical manufacturing companies.

The successful candidate will work with a group of engineers involved in the design, automation, commissioning and start-up of various processes, systems and facilities. A combination of strong technical aptitude, automation engineering skills and technical writing are the desired skill set.

This is an outstanding opportunity to join our growing team!

Full-Time | Onsite

About the Role:

We are seeking a detail-oriented and technically proficient Process Engineer who will work with a group of engineers involved in the design, automation, commissioning and start-up of various processes, systems and facilities. A combination of strong technical aptitude, automation engineering skills and technical writing are the desired skill set.

Responsibilities

• Work with Upstream equipment
• Fermentation
• Process optimization
• Process scale-up or scale-down studies
• Commissioning and Qualification
• Protocol generation and execution
• Data analysis
• Report writing
• Author SOPs
• Great communication skills (presenting, and writing)
• Protein expression/purification
• GxP (GDP, GLP, or GMP a major asset)

Minimum Requirements

• Bachelor’s or master’s degree in Biochemistry, Biology, Mechanical Engineering, Chemical Engineering, Biochemical Engineering, or related discipline.
• Required: 3+ years of experience in the biotech-pharmaceutical academic or industrial environment.
• Bioprocess experience preferred
• Fill finish experience preferred
• Basic knowledge of upstream/downstream drug substance manufacturing.
• Basic knowledge of regulatory compliance inclusive of cGMP, OSHA, EPA, FDA regulations. Familiarity with ICH guidelines and EMA regulations is a plus.
• Basic technical writing with proficiency in Excel, PowerPoint, Visio, Word, Sharepoint, etc. in addition to experience working within shared work environments.
• Demonstrated experience with manufacturing processes and equipment such as CIP systems, bioreactors, filtration skids, chromatography and lyophilization equipment.
• Basic knowledge of the Commissioning and Qualification.
• Travel within USA as needed for the projects.

Perks & Benefits:

• Competitive salary
• Full health, dental, vision, and retirement benefits
• Tuition reimbursement, PTO, and more

Job Title - Training Coordinator - Pharma Operations

Location - Easton PA

The Training Coordinator is responsible for the strategic coordination, compliance oversight, and administrative management of the employee development program within pharmaceutical operations or GMP‑regulated training. The Training Coordinator role require candidates with GMP‑regulated experience in a pharmaceutical setting. This role ensures training activities are aligned with operational demands, properly resourced, and fully compliant with company policies, OSHA standards, client requirements, and regulatory expectations. The training coordinator will maintain an audit-ready workforce ensuring employees are compliant and up to date on training records.

MUST HAVES -

• Direct experience maintaining training records in an LMS - need for accurate, audit‑ready training documentation.
• Demonstrated history of developing and delivering internal training in pharma & life sciences, as well as supporting SOP and job aid updates in regulated environments.
• Extensive experience in highly regulated FDA/GMP environments, supporting complaint management, audits, and compliance activities.
• Strong reporting skills, including trending, KPI analysis, and preparing audit‑ready materials.
• experience in warehouse‑specific training logistics, such as WMS familiarity, multi‑shift training calendars, and training around warehouse equipment certification (e.g., PIT/Forklift).
• experience with OJT verification workflows or tracking certifications/expiration dates tied to warehouse operations.
• troubleshooting classroom technology (e.g., handheld scanners or tablets used in training).

Education & Experience

• High school diploma or equivalent
• 2+ years of administrative and training coordinator experience, specifically within a background related to pharmaceutical operations or GMP‑regulated training. candidates with GMP‑regulated experience in a pharmaceutical setting.

Responsibilities:

• Develop and maintain comprehensive training schedules across all warehouse departments.
• Support facilitation of training on company policies, SOPs, safety standards, and operational systems (e.g., LMS, WMS/C3).
• Partner with warehouse leadership to ensure structured training programs are consistently executed for new hires and existing associates.

Logistics & Scheduling

• Training calendar coordination: Manage the master training calendar across 1st, 2nd, and 3rd shifts, ensuring training sessions do not disrupt peak shipping and receiving windows.
• Onboarding Logistics: Coordinate onboarding training for new associates, including safety gear (PPE) distribution, badge access, and classroom setup.
• Equipment Certification: Schedule and track practical evaluations and certifications for Powered Industrial Trucks (PIT) and other applicable equipment, ensuring only authorized personnel operate machinery.

Administrative & LMS Management

• Record Integrity: Maintain the training program within the Quality Management System and any required physical training documentation, ensuring every associate has a complete, accurate, and audit-ready training profile.
• Compliance Tracking: Proactively monitor certification and qualification expiration dates (e.g., PIT/Forklift, HazMat, Safety protocols) to prevent compliance gaps or operational disruption.
• SOP Document Control: Coordinate distribution and version control of Standard Operating Procedures (SOPs) to ensure associates are trained on current, approved processes.

Reporting & Auditing

• Audit Support: Prepare and present training documentation during internal audits, client audits, OSHA inspections, and regulatory reviews.
• Productivity Reporting: Generate reports on training completion rates and "Time to Productivity" for new hires to help Operations plan for peak seasons.
• OJT Verification: Collect, verify, and maintain On-the-Job Training (OJT) documentation to confirm hands-on competency validation by authorized supervisors.

Technical Skills:

• Advanced proficiency in Microsoft Office (Excel is critical for tracking metrics). Experience with Quality Management Systems and/or Warehouse Management Systems is a plus.
• Organization: Exceptional organizational skills with a "zero-error" approach to data entry, understanding that a missing record can lead to a regulatory finding.
• Communication: Ability to communicate clearly within a diverse workforce, from entry-level associates to senior facility management.
• Experience with "Train-the-Trainer" models in a manual labor setting.
• Ability to troubleshoot basic classroom technology (tablets, hand-held scanners used for training).
• Effective analytical, problem solving and decision-making skills (can gather and analyze data and information and draw conclusions). Able to think logically and analytically.
• Able to prioritize, organize tasks and time, and follow up. Performs responsibilities efficiently and timely. Able to balance multiple requests and meet deadlines.
• Able to work well in a team environment and as part of a team.
• Demonstrates ability to effectively lead a team to successful completion of a project.
• Knowledge of FDA and CFR requirements surrounding training

Aseptic Fill/Finish | Liquid Drug Product

Weekend Day Shift -> Friday - Sunday from 6am to 6pm (2 openings)

Weekend Night Shift -> Friday - Sunday from 6pm to 6am (2 openings)

Full-time, Direct Hire with Full Benefits

A pharmaceutical manufacturing organization is seeking a Formulation Specialist to support bulk drug product preparation within an aseptic sterile fill/finish environment. This hands-on role is responsible for formulation, equipment operation, and cGMP manufacturing activities supporting aseptic production.

The position works closely with manufacturing, quality, and technical teams to ensure safe, compliant, and efficient batch execution while contributing to process improvements and operational excellence.

Key Responsibilities

• Perform weighing, dispensing, and formulation activities for liquid drug product manufacturing
• Set up, operate, clean, and maintain formulation and processing equipment
• Execute manufacturing operations within controlled and cleanroom environments
• Complete batch documentation and manufacturing records in accordance with cGMP requirements
• Support aseptic filling operations and equipment preparation as needed
• Assist with validation runs, engineering batches, and process troubleshooting
• Train and support team members on manufacturing procedures and best practices
• Participate in continuous improvement and equipment optimization initiatives
• Collaborate cross-functionally to ensure production timelines and quality standards are met

Basic Qualifications

• High school diploma or equivalent required
• Minimum 1+ year of GMP pharmaceutical manufacturing experience or 3+ years of related manufacturing experience
• Experience operating and maintaining production equipment in a regulated environment
• Basic computer proficiency (Microsoft Office and similar systems)

Preferred Background

• Bachelor's Degree with a Scientific focus (not required)
• Experience in sterile or aseptic pharmaceutical manufacturing environments
• Knowledge of cGMP regulations and good documentation practices
• Familiarity with SAP/ERP or inventory management systems
• Strong communication skills and attention to detail

Work Environment

• Pharmaceutical manufacturing facility supporting sterile drug product production
• Cleanroom and controlled manufacturing areas required (Grade A and Grade C)
• Hands-on production role with weekend schedule coverage

Eli Lilly Concord

Title: TSMS Sterility Assurance Scientist

Type: 6 month contract w/ possible extensions

Schedule: Monday–Friday 8-5

Location: Concord site Concord, NC

Expected Compensation: $40-50/hr

Start date: ASAP

Benefits: Health, Dental, Vision, PTO, & Sick Days

Responsibilities

The Sterility Assurance Scientist is a technical role that assists in the development and implementation of the site’s sterility assurance programs and provides technical guidance and expertise in environmental monitoring, contamination control, aseptic process simulations, gowning/aseptic techniques, and cleaning/sanitization strategies, including disinfectant efficacy.

The principal role develops and implements a technical agenda and provides technical leadership for the Parenteral Process Team. This individual is also expected to serve as a mentor within the TSMS team and engage in upstream and external site activities related to sterility assurance and contamination control strategies.

Key Objectives / Deliverables

Provide oversight and technical guidance for sterility assurance programs at the manufacturing floor level.

Lead or provide technical support for sterility assurance activities including but not limited to:

• Airflow Pattern Testing
• Environmental Monitoring Performance Qualifications (EMPQ)
• Aseptic Process Simulations (APS / Media Fills)
• Cleaning, Sanitization, and Disinfection Programs
• Gowning within GMP Classified Areas
• Aseptic Processing Techniques
• Contamination Control

Additional responsibilities include:

• Assist in the development and implementation of facility monitoring and contamination control processes.
• Support development and implementation of the site contamination control strategy.
• Provide technical expertise related to cleaning and sanitization programs and disinfectant efficacy strategies.
• Support development and execution of cleanroom gowning and aseptic technique programs.

Sterility Assurance Program Support

Provide technical oversight for one or both of the following programs:

Environmental Monitoring (EM)

• Author Environmental Monitoring Performance Qualification protocols (EMPQ) and oversee execution.
• Evaluate EM data and author EM trend reports.
• Identify facility environmental isolates and maintain environmental isolate cultures.

Aseptic Process Simulation (APS / Media Fill)

• Author APS protocols and oversee execution.
• Evaluate APS data including personnel qualification results and author APS reports.
• Track and trend APS activities to ensure regulatory compliance and adherence to Global Quality Standards.

Additional Responsibilities

• Apply sterility assurance risk management principles to evaluate manufacturing processes and controls related to microbial, endotoxin, and particulate contamination risks.
• Analyze microbiological and manufacturing data to identify trends, discrepancies, and improvement opportunities.
• Provide technical support for root cause investigations associated with sterility assurance programs.
• Participate in internal and external audits as a sterility assurance subject matter expert.
• Create, execute, review, and approve technical documents and change controls related to sterility assurance programs.
• Collaborate with cross-functional teams to deliver TSMS objectives and quality goals.

Basic Qualifications

• Bachelor’s or Master’s degree in Microbiology, Biology, Biochemistry, Biochemical Engineering, Chemical Engineering, or a related scientific discipline.
• Demonstrated understanding of scientific principles related to sterile pharmaceutical manufacturing including:
• Microbiology

• Environmental Monitoring
• Sterility Assurance
• Validation
• Technical Services
• Quality Assurance within cGMP pharmaceutical manufacturing
• Senior level: 2+ years of pharmaceutical manufacturing experience (Microbiology, TSMS, Sterility Assurance, or related function)
• Principal level: 5+ years of pharmaceutical manufacturing experience (Microbiology, TSMS, Sterility Assurance, or related function)

Additional Skills / Preferences

• Strong interpersonal skills and ability to work cross-functionally within a team environment.
• Strong self-management and organizational skills.
• Strong written and verbal communication skills.
• Experience with data analysis and trending.
• Ability to wear appropriate PPE and work safely in manufacturing, warehouse, or laboratory environments.
• Ability to gown into cleanroom environments as required.

Additional Information

• Monday–Friday schedule.
• Role may initially support project activities and transition into routine manufacturing support as the facility and processes mature.
• Must be flexible to support production schedules, shutdowns, and operational needs.
• Occasional extended hours or off-hour work may be required.
• Tasks may require repetitive motion and standing or walking for extended periods.

Location: Upstate NY (Relocation from Canada welcome!)

Please note: We are only considering W2 candidates at this time. Applications from third-party vendors or C2C arrangements will not be considered.

ADVENT Engineering is an engineering and consulting firm providing expertise to the pharmaceutical and biotechnology industries. Headquartered near San Francisco, California, and with operations in the Eastern and Western US, Canada and Singapore, our company is involved in almost every facet of global pharmaceutical and biotechnology facility design and process engineering and quality system projects.

ADVENT's services include process engineering, automation engineering, project engineering, facility/system design, start up and commissioning, validation and compliance consulting for distinguished and successful biotechnology and pharmaceutical manufacturing companies.

The successful candidate will work with a group of engineers involved in the design, automation, commissioning and start-up of various processes, systems and facilities. A combination of strong technical aptitude, automation engineering skills and technical writing are the desired skill set.

This is an outstanding opportunity to join our growing team!

Full-Time | Onsite

About the Role:

We’re looking for a detail-driven HEPA Certification Coordinator to manage and maintain HEPA filter compliance across our pharmaceutical cleanroom facilities. You’ll work with internal teams and external vendors to ensure air quality standards are met and documented.

What You’ll Do:

• Oversee HEPA filter certification and scheduling
• Ensure compliance with GxP and industry standards
• Coordinate with vendors and internal teams
• Maintain accurate documentation and reports
• Support investigations and continuous improvement

What You Bring:

• 3+ years in pharma manufacturing with cleanroom experience
• Knowledge of HEPA standards, GxP
• Strong communication and organizational skills
• Bachelor’s in engineering, Science, or related field

Perks & Benefits:

• Competitive salary
• Full health, dental, vision, and retirement benefits
• Tuition reimbursement, PTO, and more

Ready to make an impact? Apply now and help us maintain the highest standards in cleanroom air quality.

TOP SKILLS PER MGR:

1. Pharma Industry Experience

2. Experience w/GxP documentation required (not GMP)

3. SOP Writing expertise

4. Patient Safety knowledge/experience (HUGE PLUS)

Job Summary:

We are seeking a skilled Technical Writer/Procedure Document Specialist to collaborate with colleagues, customers, and stakeholders on projects focused on process enhancement and continuous improvement within the Technical Writing Group. This role will emphasize the development of procedural documentation in a GxP environment, ensuring compliance and operational effectiveness, while also producing training materials and job aids.

Key Responsibilities:

- Lead a multidisciplinary team of subject matter experts, business process owners, and key stakeholders in the development, revision, enhancement, implementation, and maintenance of process and procedural documentation.

- Plan and manage multiple process development projects simultaneously, ensuring timely delivery of targeted outcomes.

- Create and write content for training programs, including user-friendly training materials and job aids that support process understanding and application.

- Utilize your knowledge of global regulations within a GxP environment to create processes and related documentation that adhere to regulatory requirements, support corporate compliance, and are inspection-ready.

- Contribute to compliance and audit/inspection readiness strategies and plans, ensuring all documentation meets necessary standards.

- Evaluate global procedural documentation against evolving industry and regulatory requirements, audit/inspection findings, and corporate policies; recommend changes as necessary based on feedback, trends, and best practices.

Qualifications:

- Education: Minimum of a BA or BS required; an advanced degree in a relevant field is desirable. Degree or professional certification in process design or change management is a plus.

Experience:

- Minimum 3+ years of experience in the design and documentation of pharmaceutical business processes and change management required.

- Experience in process training development, delivery, and/or implementation is preferred, including the creation of training content and job aids.

- GxP environment experience required

- Project Management Skills: Proven ability to manage multiple projects simultaneously; PMP certification is an advantage.

- Technical Writing: Background in pharmaceutical technical writing and development of Standard Operating Procedures (SOPs) is essential.

- Organizational Skills: Strong organizational abilities, planning, and multitasking skills; capable of prioritizing multiple projects while meeting tight deadlines.

- Adaptability: Ability to work effectively under pressure and adapt to changing situations with attention to detail.

- Technical Proficiency: Proficient in common desktop tools, including MS Word, MS Excel, MS Project, and Visio and PowerPoint. Sharepoint and MS Teams and Forms a plus.

- Communication Skills: Strong verbal and written communication skills with an in-depth under-standing of pharmaceutical business processes, regulations, guidelines, and industry standards relating to compliance.

Critical Skills/Experience

1) Experience in a GxP environment

2) Strong project management skills with a proven ability to manage multiple projects simultaneously

3) Background in pharmaceutical technical writing, specifically Standard Operating Procedures (SOPs)

4) Ability to create training materials and job aids that facilitate process understanding and implementation

5) Proficiency in using Visio for process mapping and diagram creation

6) Ability to work on critical initiatives under pressure while maintaining a keen attention to detail

Sr. Quality Automation and AI CSV Engineer

The Senior Automation and AI CSV Engineer will lead the design, implementation, and validation of automated systems and AI-driven solutions within a sterile injectable pharmaceutical manufacturing environment. This role ensures compliance with regulatory requirements (FDA, EMA, ICH) and company standards for computerized systems, automation platforms, and AI-enabled technologies used in production, quality control, and data analytics.

Essential Duties & Responsibilities

• Automation & AI Validation:
• Develop and execute validation strategies for automated systems, robotics, and AI-based tools in compliance with GAMP 5, 21 CFR Part 11, FDA’s CSA for Production and Quality System Software, Annex 11, Annex 22, and PIC/S.
• Perform risk assessments and ensure data integrity for AI-driven decision-making systems.
• Author and review validation documentation (URS, FS, DS, IQ/OQ/PQ protocols, reports).
• System Lifecycle Management:
• Oversee system implementation, upgrades, and change control for automation and AI platforms.
• Collaborate with IT, Engineering, and Quality teams to maintain validated state of systems.
• Regulatory Compliance:
• Ensure adherence to cGMP, FDA, EMA, and global regulatory guidelines for sterile injectable manufacturing.
• Support audits and inspections by providing validation evidence and technical expertise.
• Innovation & Continuous Improvement:
• Identify opportunities to integrate AI and advanced analytics for process optimization and predictive maintenance.
• Drive digital transformation initiatives.
• Quality Oversight & Approval:
• Provide independent quality oversight for automation and AI validation activities.
• Review and approve validation protocols, reports, and change control documentation to ensure compliance and data integrity.
• Act as a quality representative during system implementation and qualification phases.
• Adhere to company and departmental timelines with high accuracy and quality.
• Maintain an atmosphere of teamwork, cordiality, and respect towards co-workers.
• Performs other duties as assigned.

Core Values

This position is expected to operate within the framework of our Core Values:

• Center on People: We commit to support the well-being of our patients. We are committed to treating our employees and those we serve as valued partners. By placing people at the heart of our actions, we actively engage, invigorate, acquire knowledge, and grow together.
• Are Proactive & Agile: We embody a culture of engagement and action. With a hands-on approach, we fearlessly adapt to change. We anticipate, respond swiftly and efficiently to ignite a spirit that propels us towards extraordinary outcomes.
• Act Ethically: We are committed to consistently conducting our business in an ethical, compliant, and socially aware manner, in line with our purpose of positively impacting lives. We actively cultivate diversity, equity, inclusion & sustainability in our workplace.
• Constantly Improve: We are committed to a collaborative & proactive effort to improve our products, systems, processes, and services by reducing waste, increasing efficiency & improving quality.
• Are Accountable: We think, act, and communicate with honesty, transparency, and clarity in alignment with our core values. We don't compromise our values for near term gain. We take accountability & ownership of our work, actions, successes, and setbacks. We strive to deliver our best as we shape the future.

Knowledge, Skills & Abilities

• Excellent organizational and project management skills.
• Excellent oral and written communication skills.
• Ability to work independently with minimal supervision and as part of a cross-functional team.
• Advanced knowledge of Automation and CSV/CSA principles, industry guidance, regulatory requirements, cGMP practices, and ICH guidelines.
• Strong project management and cross-functional leadership skills.
• Ability to author strong technical reports free of errors.
• Advanced knowledge with Microsoft Office Suite, and various GMPS systems such as Veeva eQMS, Maximo CMMS, BMS, LIMS, CDS, and ERPs.
• Familiarity with SCADA, PLC, MES, and AI platforms from simple context analysis tools to large language modeling, prompt engineering and the role of human interaction for process engineering and establishment of trustworthy data.
• Advanced troubleshooting and problem-solving skills.
• Ability to manage multiple projects concurrently and under tight time constraints.

Education & Experience

• Bachelor’s degree in Engineering, Computer Science, Pharmaceutical Sciences, or related field required
• Master’s degree in Engineering, Computer Science, Pharmaceutical Sciences, or related field preferred
• Minimum of 8 years’ experience in pharmaceutical automation and computerized system validation.
• Strong knowledge of sterile injectable manufacturing processes and aseptic techniques.
• Hands-on experience with AI/ML applications in manufacturing or quality systems preferred.
• Expertise in GAMP 5, 21 CFR Part 11, Annex 11 and knowledge of Annex 22 compliance.
• Proficiency in risk-based validation and data integrity principles.

Working Conditions

• Working conditions include general office environment.
• Business demands may require working extended hours.

About The Job

Arcadis is the world's leading company delivering sustainable design, engineering, and consultancy solutions for natural and built assets.

We are more than 36,000 people, in over 70 countries, dedicated to improving quality of life. Everyone has an important role to play. With the power of many curious minds, together we can solve the world’s most complex challenges and deliver more impact together.

Role description:

Arcadis is seeking a skilled Process Engineer focused on spray drying processes for tablets or dry powders for a pharmaceutical client in Norton, MA. This role supports scale-up, optimization, and process validation within GMP environments, ensuring product quality, yield, and robust manufacturing performance.

Role accountabilities:

• Lead and optimize spray drying processes for tablets or powders from development through commercialization.
• Design, execute, and analyze experiments to scale processes from pilot to commercial scale; apply statistical methods and design of experiments (DOE) where appropriate.
• Develop and maintain process validation documentation (IQ/OQ/PQ), process controls, and robust process parameters (RPPs).
• Implement process analytical technology (PAT) and Quality by Design (QbD) approaches to monitor critical quality attributes (CQAs) and critical process parameters (CPPs).
• Collaborate with formulation scientists, development, manufacturing, and quality teams to ensure compliant, scalable processes.
• Troubleshoot process deviations, root cause analysis, and implement corrective/preventive actions (CAPA).
• Review and update standard operating procedures (SOPs) and batch records to align with regulatory requirements (GMP, FDA/EU).
• Support risk assessments, process safety reviews, and equipment qualification activities (IQ/OQ/PQ) for spray drying equipment.
• Prepare technical reports, process summaries, and deviation/validation documentation for regulatory submissions.
• Stay current with industry best practices in spray drying, particle engineering, and pharmaceutical manufacturing.

Qualifications

• Bachelor’s degree in Chemical Engineering, Pharmaceutical Engineering, or a related field
• Hands-on experience with pharmaceutical spray drying processes (tablets or dry powders) in GMP environments.
• Strong understanding of PAT, QbD, DOE, FTIR/NIR/Raman for inline analysis is a plus.
• Experience with process validation (IQ/OQ/PQ) and equipment qualification for spray dryers.
• Familiarity with regulatory expectations (FDA, EMA) and good documentation practices.
• Proficiency in data analysis, statistical tools, and process optimization software.
• Excellent problem-solving, communication, and cross-functional collaboration skills.

Why Arcadis?

We can only achieve our goals when everyone is empowered to be their best. We believe everyone's contribution matters. It’s why we are pioneering a skills-based approach, where you can harness your unique experience and expertise to carve your career path and maximize the impact we can make together.

You’ll do meaningful work, and no matter what role, you’ll be helping to deliver sustainable solutions for a more prosperous planet. Make your mark, on your career, your colleagues, your clients, your life and the world around you.

Together, we can create a lasting legacy.

Join Arcadis. Create a Legacy.

Our Commitment to Equality, Diversity, Inclusion & Belonging

We want you to be able to bring your best self to work every day which is why we take equality and inclusion seriously and hold ourselves to account for our actions. Our ambition is to be an employer of choice and provide a great place to work for all our people. We are an equal opportunity and affirmative action employer. Women, minorities, people with disabilities and veterans are strongly encouraged to apply. We are dedicated to a policy of non-discrimination in employment on any basis including race, creed, color, religion, national origin, sex, age, disability, marital status, sexual orientation, gender identity, citizenship status, disability, veteran status, or any other basis prohibited by law.

Arcadis offers benefits for full time and part time positions. These benefits include medical, dental, and vision, EAP, 401K, STD, LTD, AD&D, life insurance, paid parental leave, reward & recognition program and optional benefits including wellbeing benefits, adoption assistance and tuition reimbursement. We offer nine paid holidays and 15 days PTO that accrue per year. Salaries will vary and are based on several factors, such as experience, education, budget, internal equity, project and location.

Job Summary

We are seeking a QA Specialist with GMP experience to provide basic quality support for a pharmaceutical manufacturing environment. This role will support day-to-day quality assurance activities, with a strong focus on deviation management and GMP documentation. The ideal candidate will have experience working in a regulated pharmaceutical setting and be comfortable supporting investigations and quality systems.

This position is on-site in Smyrna, GA and is a one-year contract role supporting quality operations.

Key Responsibilities

• Provide Quality Assurance support for manufacturing and quality systems in a GMP-regulated pharmaceutical environment.
• Review and assist with deviation investigations, ensuring timely documentation and closure.
• Support GMP documentation review, including batch records, SOPs, and quality records.
• Assist in root cause analysis and corrective/preventive actions (CAPA) related to deviations.
• Ensure compliance with GMP regulations and internal quality standards.
• Collaborate with manufacturing, quality control, and regulatory teams to resolve quality issues.
• Maintain accurate documentation and support inspection readiness.
• Participate in quality meetings and provide basic QA support across quality systems.

Qualifications

Required

• Bachelor’s degree in Life Sciences, Chemistry, Biology, or related field.
• 1–3+ years of experience in the pharmaceutical or biotech industry.
• Experience working in a GMP-regulated environment.
• Hands-on experience with deviation investigations and quality documentation