Pharmaceutical Sciences Journal Jobs in Usa

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• Support the setup and launch of the new Process Technologies & Development lab, including workspace organization, equipment installation support, and qualification readiness.
  
• Operate, maintain, and troubleshoot a broad range of primary container and analytical laboratory equipment, including:
  
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  • Leak detection systems
    
  • Headspace analyzers
    
  • Optical and particle counting microscopes
    
  • MicroCT scanners
    
  • Automatic filling equipment
    
  • Filtration and mixing tanks
    
  • Balances and related instrumentation
    
  
  
  
• Independently refine and develop laboratory processes and equipment workflows to improve efficiency, robustness, and usability.
  
• Maintain accurate equipment logs, calibration records, and instrument readiness documentation.
  
• Ensure laboratory organization, including consumables tracking, chemical inventory, and compliance with safety, quality, and documentation requirements.
  
• Partner with Facilities, Metrology, EH&S, and cross-functional Process Development teams to support seamless lab operations and timely issue resolution.
  

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• Apply sound scientific judgment in planning and troubleshooting experimental studies.
  
• Support method development, workflow optimization, and evaluation of new technologies relevant to primary container development and characterization.
  
• Drive continuous improvement in lab workflows, equipment utilization, and operational efficiency.
  
• Maintain a culture of cleanliness, organization, and scientific excellence within the laboratory.
  

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• Bachelor's or Master's degree in Engineering, Chemistry, Biology, Pharmaceutical Sciences, or a related technical field.
  
• Hands-on laboratory experience (academic or industry) with strong familiarity in equipment operation and laboratory best practices.
  
• Demonstrated experience designing and executing experiments with strong attention to detail and scientific rigor.
  
• Excellent organizational skills with a proven ability to maintain a clean, structured, and efficient laboratory environment.
  
• Strong communication skills and ability to manage multiple priorities in a fast-paced environment.
  

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• Experience supporting laboratory setup, including equipment installation, qualification, and initial operational readiness.
  
• Familiarity with a broad range of laboratory equipment, including routine operation, troubleshooting, and maintenance.
  
• Experience with studies involving:
  
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  • Container Closure Integrity (CCI)
    
  • Extractables and Leachables
    
  • Device-drug interface evaluations
    
  • Fill-finish operations
    
  
  
  
• Ability to design and refine lab workflows that improve efficiency and usability across teams.
  
• Prior experience working within cross-functional development teams.
  

We are seeking a hands-on QC/QA Hybrid Manager to lead our quality control operations and compliance systems in a new peptide manufacturing lab. This role combines day-to-day QC supervision, batch review, and analytical oversight with strategic quality management, including SOP development, CAPA, and regulatory readiness.

The ideal candidate thrives in a startup environment, has experience with regulated laboratory operations, and is comfortable both mentoring staff and building robust quality systems from the ground up.

Key Responsibilities

Quality Control Operations

• Supervise QC testing workflows, including HPLC, LC-MS/MS, endotoxin, sterility, and CoA generation.
• Approve or reject batches for release in collaboration with production and analytical staff.
• Manage sample scheduling, instrument calibration, and lab documentation practices.
• Troubleshoot QC and analytical issues with the Lead Analytical Chemist.

Quality Management / Compliance

• Develop, implement, and maintain SOPs, batch records, change control, and CAPA processes.
• Ensure lab operations comply with cGMP, USP, FDA, and state Board of Pharmacy regulations.
• Lead regulatory and internal audits; prepare responses for inspections.
• Ensure data integrity, documentation accuracy, and environmental monitoring compliance.

Team Leadership

• Mentor and manage QC staff and lab technicians.
• Collaborate with Lead Analytical Chemist, Production Lead, and Lab Director to coordinate lab operations.
• Foster a culture of compliance, accountability, and continuous improvement.

Required Qualifications

• Bachelor’s degree in Chemistry, Biochemistry, Pharmaceutical Sciences, or related field.
• 5–10+ years in regulated lab environments with hands-on QC and quality oversight.
• Proven experience with HPLC, LC-MS/MS, sterility, and endotoxin testing.
• Strong knowledge of cGMP, USP, FDA regulations, and quality systems.
• Experience writing and reviewing SOPs, batch records, and CAPAs.
• Demonstrated leadership and team management experience.
• Excellent documentation, analytical, and problem-solving skills.

Preferred Qualifications

• Experience in 503B outsourcing facilities, sterile compounding, or injectable manufacturing.
• Prior exposure to FDA, State BOP, or third-party audits.
• Knowledge of peptide chemistry, lyophilization, and stability testing.
• Ability to work in a fast-growing startup lab environment.

Compensation & Benefits

• Salary: $115,000 – $145,000, depending on experience.
• Total Comp: Up to $160,000 with performance-based bonus.
• Health, Dental, Vision, 401K, Life Insurance, PTO.
• Opportunity to grow into Lab Director or QA leadership roles as the lab expands.
• Professional development support (conferences, certifications).

Our client is seeking a strategic and experienced leader to oversee all aspects of Chemistry, Manufacturing, and Controls (CMC) from lead optimization through commercialization. This role will drive formulation, process development, clinical supply chain, and regulatory strategy—especially focused on Phase 3 and long-term extension studies.

Key Responsibilities:

• Lead internal teams and external CDMO partners across CMC functions
• Oversee manufacturing, analytical development, tech transfer, and clinical supply logistics
• Ensure regulatory readiness and author CMC sections for global filings (INDs, NDAs, IMPDs)
• Collaborate cross-functionally with Regulatory, Quality, and Clinical teams
• Manage department budgets and ensure operational excellence across the portfolio

Qualifications:

• PhD in pharmaceutical sciences, chemistry, or related field
• 15+ years of industry experience, including 10+ years in senior CMC leadership
• Deep expertise in injectable drug products and synthetic peptide manufacturing
• Strong understanding of global regulatory guidelines (ICH, FDA, EMA, USP)
• Proven success managing CDMO relationships and leading cross-functional teams

About Stratacuity:

Whether you are seeking a career change or simply interested in becoming part of our network, you will appreciate the ethics guiding each Stratacuity team member. We build lasting relationships with exceptional biopharmaceutical talent and take great care to protect your personal information. Upon receiving your inquiry, you may be directly contacted by a Stratacuity team member to discuss your career goals. We will not share your information with anyone without your direct prior consent.

PROVEN SCIENTIFIC PLACEMENT™

Stratacuity is an Equal Employment Opportunity/Affirmative Action Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, age, sexual orientation, gender identity, national origin, disability, protected veteran status, or any other characteristic protected by law. Stratacuity will consider qualified applicants with criminal histories in a manner consistent with the requirements of applicable law. If you have visited our website in search of information on employment opportunities or to apply for a position, and you require an accommodation in using our website for a search or application, please contact us.

Consultant, Commercial Analytics Manager

Summary

Our mid-sized, growing pharmaceutical client is seeking a Data Analyst professional who is highly motivated and a strategic individual responsible for supporting the commercial success of our clients pharmaceutical brands. This role combines advanced analytics, data visualization, and storytelling to generate actionable insights that influence brand strategy and leadership decision-making. The ideal candidate will bring strong analytical capabilities, expertise in pharmaceutical data, and a collaborative mindset to drive performance across the organization.

Responsibilities

• Translate complex analytics into clear, actionable insights.
• Develop compelling, data-driven narratives to support brand strategy and executive decisions.

Power BI Development

• Design, build, and maintain interactive, user-friendly dashboards to track brand and portfolio performance.
• Continuously enhance visualizations based on evolving business needs.

Ad-Hoc Analytics & Creative Problem Solving

• Conduct deep-dive analyses to support new brand launches and optimize in-line brands.
• Apply creative thinking to uncover insights and solve complex business questions.

Portfolio Performance Management

• Monitor and analyze KPIs across a portfolio of assets.
• Identify trends, risks, and opportunities to inform strategic decisions.

Vendor Management

• Coordinate with external analytics vendors to ensure timely, high-quality deliverables.

Cross-Functional Collaboration

• Partner closely with Marketing, Sales, Market Access, Forecasting, Finance, and Market Research teams to inform brand strategy and tactical execution.

Data Integrity & Industry Awareness

• Ensure data accuracy, consistency, and integrity across all reports and tools.
• Stay abreast of industry trends, competitive intelligence, and evolving analytical methodologies.

Qualifications/Experience:

• 3+ years of experience in pharmaceutical data science, brand analytics, or commercial analytics, with at least 2 years in the pharmaceutical or life sciences industry.
• Experience with specialty pharmacy data and related analytics.
• Strong command of pharma data sources (e.g., IQVIA, Symphony, Komodo, claims data, specialty pharmacy, field activity data).
• Proficiency in data visualization & analytics tools (Power BI, Tableau, Excel, SQL, Python, or SAS).
• Preferred: Experience in nephrology, rare disease, oncology, or specialty pharmacy distribution.
• Education: Bachelor’s degree in Business, Statistics, Economics, Life Sciences, Computer Science, or a related field.

Term & Start

• 12 month contract – possible option to extend.
• Start 2-3 weeks from an offer.
• Remote with ability to go onsite 1 X per week in Princeton, NJ
• Benefits available (Medical, Dental, Vision, 401k

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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IQVIA is a leading global provider of research and development, commercial solutions, and technology-enabled services to the life sciences industry. We help customers accelerate innovation and improve patient outcomes by combining deep scientific expertise with advanced data assets, transformative technology, and integrated services. IQVIA Digital builds on this foundation to deliver omnichannel engagement strategies powered by privacy-optimized data, advanced analytics, and scalable technology, enabling pharmaceutical companies to connect with healthcare professionals and patients in meaningful, measurable ways.

The Pharma Segment Lead defines and drives IQVIA Digital's segment-level strategy for pharmaceutical clients. This role sets the vision for how we position our capabilities and value proposition, ensuring alignment with client needs and market trends. The Pharma Segment Lead combines strategic thinking with hands-on storytelling, creating compelling narratives and resources that enable sales, marketing, and product teams to win and grow business. The role is accountable for measurable commercial outcomes and plays a critical part in IQVIA Digital's continued growth trajectory.

Segment Strategy:

• Develop and own the segment strategy for IQVIA Digital offerings across large pharma and other prioritized segments, including key accounts and EBP (pre-commercial, small, and mid-sized pharma).
• Identify growth opportunities, prioritize products and solutions, and influence product development roadmaps to address gaps.
• Participate in strategic forums such as product summits to pressure-test ideas and ensure alignment with market needs.
• Monitor market trends, competitive dynamics, and customer needs to inform strategy and scenario planning.

Strategic Storytelling:

• Craft and adapt executive-ready narratives that articulate IQVIA Digital's vision, capabilities, and proof points, tailored by segment and therapeutic area (oncology, rare disease, immunology, cardiometabolic).
• Build clear, concise, and compelling presentations for client innovation days and senior-level engagements.

Collaboration & Client Engagement:

• Lead planning for client innovation days and strategic meetings, partnering with Sales and Product to define objectives, storyboards, and partnership opportunities.
• Serve as a commercial strategy SME in high-level pharma client meetings and innovation days.
• Support Sales in key strategic meetings by co-leading preparation and delivery of material.
• Collaborate with Marketing and Thought Leadership teams to shape and amplify IQVIA Digital's points of view, ensuring consistency across external engagements.

Commercial Enablement:

• Package offerings for lead generation and sales enablement, ensuring resources are current and aligned with GTM priorities.
• Contribute to strategic account reviews and cross-functional initiatives to integrate IQVIA Digital solutions into broader offerings.

Partner Strategy & Innovation:

• Contribute to GTM partner strategy including leading evaluation, recommendation, and implementation of partners.
• Identify emerging technologies or partnerships that could enhance IQVIA Digital's value proposition.

Customer Experience & Data-Driven Insights:

• Champion a customer-centric approach to solution design and engagement.
• Leverage data and analytics to inform strategy and track performance.

- 10+ years in pharmaceutical brand and/or marketing roles; agency experience strongly preferred.

- Management consulting experience in life sciences or healthcare strategy is highly desirable.

- Recognized industry presence through publications, speaking engagements, or thought leadership contributions.

- Proven ability to develop and deliver strategic narratives and executive-ready presentations.

- Deep understanding of pharma customer needs across functions and market trends shaping future requirements.

- Experience across major therapeutic areas (oncology, rare disease, immunology, cardiometabolic).

- Exceptional skills in strategic thinking, storytelling, slide design, and cross-functional collaboration.

Approximately 5% (one trip per quarter for client meetings or industry events).

To be eligible for this position, you must reside in the same country where the job is located.

IQVIA is proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, status as a protected veteran, or any other status protected by applicable law.

The potential base pay range for this role, when annualized, is $121,400.00 - $338,400.00. The actual base pay offered may vary based on a number of factors including job-related qualifications such as knowledge, skills, education, and experience; location; and/or schedule (full or part-time). Dependent on the position offered, incentive plans, bonuses, and/or other forms of compensation may be offered, in addition to a range of health and welfare and/or other benefits.

Role at a Glance

Employment Type: Full-time | Department: Quality | Reports to: Director of Quality

Experience Level: 1–3 years hands-on QC experience in a manufacturing environment ( preferably nutraceutical, food, animal health or pharmaceutical).

Work Location: Onsite – Noblesville, IN; Travel: 0-10%.

About Verdure Sciences

For nearly three decades, Verdure Sciences has been pioneering botanical ingredient excellence. From our sustainable sourcing partnerships to our branded ingredients like Longvida® Curcumin and Pomella® Pomegranate, our partners—global consumer brands—trust our commitment to botanical integrity and quality.

You will be a key member of our Quality team ensuring that every batch meets specifications, regulatory requirements, and customer standards. The focus is practical, day-to-day QC execution: coordinating testing with contract labs, reviewing data for release, and maintaining right-first-time documentation under cGMP.

We are specifically prioritizing candidates with hands-on QC experience in manufacturing environments.

Key Responsibilities

• Prepare samples and coordinate testing with qualified third‑party labs aligned to customer specifications and QC test plans.

• Review physical, chemical, and microbiological data; resolve discrepancies and confirm compliance to specifications for batch release.

• Generate Certificates of Analysis (CoA), verify labels, and execute batch release documentation with right‑first‑time accuracy and communicate with suppliers.

• Manage traceability, retains, and stability program records (sampling plans, storage, pulls, and data trending).

• Support in‑house testing routines as needed.

• Maintain document control: specifications, test methods, SOPs, and change control records.

• Participate in quality events: nonconformances, investigations, CAPA/VCAR creation, and effectiveness checks.

• Partner cross‑functionally (Supply Chain, R&D, Sales/Account teams) to resolve issues and meet customer quality expectations.

• Assist with internal/external audits (e.g., NSF, USP, Organic, Non‑GMO) and vendor/contract lab qualifications.

• Stay up to date with industry regulations and best practices related to botanical ingredients and dietary supplements.

What You’ll Bring (Required)

• Bachelor’s degree in a scientific discipline (Chemistry, Biology, Food Science or similar).

• 1-3 years of paid, hands‑on QC experience in dietary supplement, food, animal health or pharmaceutical manufacturing.

• Working knowledge of cGMP (e.g., FDA 21 CFR 111) and quality systems (deviations, CAPA, change control, data integrity).

• Experience reviewing third‑party lab reports and in‑house data; confident interpreting common analytical and microbiological methods.

• Proficiency creating CoAs and maintaining controlled documents; strong attention to detail and organization.

• Fluency with Microsoft Office and Adobe.

• Clear, professional communication skills and a collaborative approach with vendors and internal teams.

Preferred experience:

• Direct experience with dietary supplement/botanical regulations and audits (NSF, USP, Organic, Non‑GMO).

• Qualifying and managing third‑party labs; vendor performance monitoring.

• Statistics/data trending for QC (e.g., control charts, out‑of‑trend checks).

• Electronic quality/document systems and CRM systems (TrackWise, Veeva, SharePoint, Hubspot).

Work Environment & Schedule

Onsite at our Noblesville, IN office/lab | Monday–Friday, 8:30 a.m.–5:30 p.m.

Our Hiring Approach

Verdure Sciences is an Equal Opportunity Employer. We consider all qualified applicants without regard to protected characteristics and provide reasonable accommodation as required by law.

If you bring experience from botanical extracts, herbal ingredients, or plant-based nutraceuticals and have a discovery mindset for innovative quality solutions, we'd love to connect. This is your opportunity to make a meaningful impact in an industry where quality genuinely matters.

Work authorization: Applicants must be currently authorized to work in the United States on a full‑time basis.

#BotanicalIngredients #Quality #PlantBased #vsCares #Indiana #Hiring #vsLongvida #vsPomella

Join the Team! Is technology your passion? Do you want to work with smart, forward-thinking individuals? Do you want to grow in a career you love? At Align, our professionals are the key to our success.

We dont just hire talent, we invest in exceptional people who are forward-thinking, results-driven, and passionate about what they do.

Were a group of tech-savvy professionals who are motivated by making an impact.

Our culture is one of unbounded opportunity that celebrates the passions, skills and ideas of our teamwork hard, play hard, be smart! We believe great communities lead to great companies.

Thats why we offer a dynamic workplace where you feel inspired, engaged and innovative.

We offer professionals opportunities to train in the leading technologies, make an impact within the industry and acquire valuable new skills whether on client sites or in one of our regional offices.

Position Overview As an Associate Data Center Cabling Superintendent, you will support large-scale cabling installations for major AI and hyperscale data centers across the U.S.

This hybrid role blends field leadership with hands-on work, ideal for someone who has grown beyond a Foreman role but is not yet a full Superintendent.

Youll assist the Superintendent with planning, standards enforcement, and on-site execution while working directly with technicians, contractors, and vendors.

This role is heavily field-facing and requires strong technical skills, attention to detail, and the ability to help keep teams aligned with project timelines and quality expectations.

This is a full-time salaried role offering $90,000-$115,000, full benefits, project bonuses, paid travel, and advanced training.

This role is open in all hiring-authorized U.S.

states (AZ, AR, CA, CO, CT, DC, DE, FL, GA, IL, IA, MD, MA, MI, MO, NH, NJ, NY, NV, NC, OH, PA, RI, SC, TN, TX, UT, VT, VA, WA, WI).

Preferred hiring regions: AZ, VA, NJ, NY, and TX.

This position requires 50%-70% travel to project sites nationwide, including AI build locations.

Key Responsibilities Support structured cabling installations in new data center white space and help coordinate daily work for cabling crews under the Superintendent.

Perform on-site QA checks for fiber/copper terminations, labeling, routing, and test results while reinforcing jobsite safety.

Assist with cabling standards, tracking sheets, patch schedules, port maps, and drawing reviews to ensure work meets TIA/BICSI specifications.

Communicate field progress, schedule risks, and material needs to project leadership.

Support documentation, RFIs, change orders, daily reports, and QA/QC corrective actions.

Required Qualifications 2-4 years experience in structured cabling, low-voltage, or fiber optic systems (data center or mission-critical preferred).

Experience leading small cabling crews (foreman or lead technician level).

Ability to read cabling drawings, rack elevations, and labeling standards.

Experience using fiber testing tools (OLTS, OTDR, VFL).

Strong Excel skills for port mapping, tracking, and documentation.

Comfortable working in live data center environments with fast-paced schedules.

Willingness to travel 50-70% and work extended hours during active builds Preferred Qualifications Experience supporting data center cabling deployments.

Understanding of racks, containment systems, and cable pathways.

Familiarity with TIA/EIA or BICSI standards.

Certifications such as BICSI Technician or Installer II.

To support a fair, consistent, and high-quality hiring experience, some interviews may be recorded.

These recordings help our team focus fully on the conversation at hand, rather than note-taking, and allow us to better evaluate and improve our recruitment process.

Recordings are used solely for internal purposes such as training, quality assurance, and process improvement.

Candidates will be informed in advance and asked to provide consent before any recording takes place.

PM26 Align is a premier global provider of technology infrastructure solutions.

Align specializes in designing and deploying technology infrastructure solutions from the data center to the desktop as well as providing managed IT services for clients.

Our professional services team, which includes Data Center Solutions , provide strategic consulting, design, project management, engineering, implementation and support.

Our best-in-class Managed Services team provides IT services and cybersecurity advisory for clients within the Alternative Investment industry.

Align is a Microsoft Tier 1 Cloud Solutions Provider (CSP) and Gold Partner.

Our client centric approach and passion for driving IT innovation has enabled us to provide tailored solutions and business transformations for over three decades.

Leading firms have relied on Align to provide forward-thinking technology strategies that support their current and future business needs.

Our teams have flawless track records of delivering technical solutions and have established long-standing relationships with an impressive client list of both Global 1000 and SMB clients.

We work across a diverse list of industries including financial services, life sciences (pharmaceutical and health care), retail, technology, media and telecommunications.

For more information, visit: PI81c1083bdd7a-25448-39863216

Kelly® Science & Clinical is seeking a Quality Assurance Validation Specialist for a contract position at a premier pharmaceutical client in Irvine, CA 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 Empowering Experts.

Job Title: QA Validation Specialist (Contract)

Duration: 10 months

Location: Irvine, CA (onsite)

Rate: $38–40/hr.

This position involves hands-on ownership of equipment, facility, and laboratory validations. Ideal for experienced validation professionals who excel in regulated environments and enjoy driving projects from protocol development through audit-ready execution.

RESPONSIBILITIES:

• Assists in assuring facility, manufacturing, packaging, and Laboratory equipment are qualified to the required cGMP standards.
• Authors/approves and executes qualification protocols and reports.
• Schedules, plans, manages performance qualifications, calibration and maintenance of equipment and utility systems and laboratory Instruments in coordination with operations, Quality Control and maintenance.
• Assists sourcing and procurement of facility equipment and Laboratory Instruments through completion of following tasks
• Qualification of Vendors Selected.
• Input to the development of the URS/FRS/DDS.
• Assists with the routine calibration and maintenance of the Validation Master Plan for the site.
• May present qualification studies to Regulatory and Client Auditors as required.
• Assists with the design, maintenance, and continual improvement of the qualification system in line with cGMP standards.
• Provides technical expertise and guidance on qualification policies and procedures and the implementation of those within the Production and Quality functional areas.
• Occasionally supervises specialized contract personnel and outside vendors in the performance of contract services.
• Summarizes studies and authors qualification reports in compliance with the cGMP standards and in a timely manner.
• Develops and executes matrix type validations where applicable for processes and equipment with adequate supporting rationales.
• Initiates and investigates exception reports and non-conformances, associated with the qualification studies. Troubleshoots and resolves technical issues.
• Other responsibilities and special projects will be assigned based on business and customer needs.

QUALIFICATIONS:

• Bachelor’s degree in Sciences
• 5+ year’s of experience in a highly regulated pharmaceuticals industry or related field
• Strong working knowledge of cGMP and regulatory standards for validation.
• Experience in writing and reviewing SOPs, GMPs, governmental regulations and/or protocols for accuracy, traceability and compliance.
• Demonstrated experience with qualification of commercial processing a packaging equipment.
• Proven track record of managing projects from start to finish on time and on budget.

What happens next:

Once you apply, you’ll proceed to next steps if your skills and experience look like a good fit. But don’t worry – even if this position doesn’t work out, you’re still in our network. That means our team of expert Science & Clinical recruiters will have access to your profile, making your opportunities limitless.

Kelly® Science & Clinical is seeking a Document Control & Training Manager for a Direct Hire position at a leading specialty pharmaceutical company in Sacramento, CA. 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.

Salary:

$80-90k

Overview:

In this role, you will lead and mentor teams to manage document control and GMP training programs, ensuring regulatory compliance and inspection readiness, driving digital transformation, supporting cross-functional collaboration, and fostering a culture of continuous improvement and operational excellence within a fast-growing pharmaceutical and biotech organization.

Schedule:

Monday-Friday, standard working hours

Responsibilities:

• Lead and Develop Teams: Direct, mentor, and inspire the Document Control and GMP Training teams, fostering growth, accountability, and continuous improvement.
• Set Strategic Direction: Establish KPIs, objectives, and overall strategy for document control and training in alignment with organizational quality goals.
• Champion Regulatory Compliance: Ensure robust document management and training programs meet global regulatory requirements (21 CFR 210/211, EU GMP) and maintain inspection readiness.
• Oversee Document Lifecycle: Supervise the creation, organization, revision, archival, and retrieval of critical documents such as SOPs, Master Batch Records, and logbooks for multi-product/multi-site operations.
• Manage GMP Training Programs: Oversee employee training curricula, ensuring all staff are qualified, compliant, and prepared for evolving processes or regulatory changes.
• Drive Process Improvement: Proactively identify workflow bottlenecks, elevate document control best practices, and implement scalable solutions across the organization.
• Lead Digital Transformation: Act as the Business System Owner for electronic document and training management systems, overseeing system configuration, validation, and integrity per regulatory standards (21 CFR Part 11).
• Support Audits and Inspections: Represent quality systems during FDA/EMA audits, regulatory inspections, and customer visits, and deliver improvement strategies to leadership.
• Collaborate Cross-Functionally: Work closely with QA, Manufacturing, Regulatory, IT, and Engineering teams to drive seamless quality operations and support remediation efforts as needed.
• Uphold Culture and Standards: Set clear policies and productivity benchmarks, promote ethical practices, and cultivate a strong culture of operational excellence and compliance company wide.

Qualifications:

• Bachelor’s degree in Science, Engineering, or related field, Master’s degree strongly preferred.
• 8+ years of QA experience in a GMP-regulated environment.
• 3+ years of people management experience.
• Extensive knowledge of cGMP (21 CFR 210/211), EU GMP, GDP, 21 CFR Part 11, and ALCOA data integrity principles.
• Demonstrated expertise as a Business System Owner for digital Document Control/Training systems.
• Proven experience supporting successful regulatory inspections and customer audits.
• Superior project management, change leadership, and communication skills.