Bedford, New Hampshire, United States · On-site
Life changing therapies. Global impact. Bridge to thousands of biopharma companies and their patients. We are PCI. Our investment is in People who make an impact, drive progress and create a better tomorrow. Our strategy…
Skills: Batch Record Review, Lot Disposition, Quality System Review, Deviation Management, CAPA
Rockford, Illinois, United States · On-site
$19/hr–$22/hr
Life changing therapies. Global impact. Bridge to thousands of biopharma companies and their patients. We are PCI. Our investment is in People who make an impact, drive progress and create a better tomorrow. Our strategy…
Skills: Warehouse coordination, Logistics, Transportation scheduling, Waste management, Forklift maintenance scheduling
Philadelphia, Pennsylvania, United States · On-site
Life changing therapies. Global impact. Bridge to thousands of biopharma companies and their patients. We are PCI. Our investment is in People who make an impact, drive progress and create a better tomorrow. Our strategy…
Skills: Equipment repair, Preventive maintenance, Corrective troubleshooting, Packaging machinery, Mechanical repair
Rockford, Illinois, United States · On-site
$70k–$87k/yr
Life changing therapies. Global impact. Bridge to thousands of biopharma companies and their patients. We are PCI. Our investment is in People who make an impact, drive progress and create a better tomorrow. Our strategy…
Skills: Project management, Budget management, Client relationship management, Supply chain management, Contract management
Stamullen, Leinster, Ireland · On-site
Life changing therapies. Global impact. Bridge to thousands of biopharma companies and their patients. We are PCI. Our investment is in People who make an impact, drive progress and create a better tomorrow. Our strategy…
Skills: Maintenance, Electrical systems, Mechanical systems, PLC programming, GMP
Dundalk, Leinster, Ireland · On-site
Life changing therapies. Global impact. Bridge to thousands of biopharma companies and their patients. We are PCI. Our investment is in People who make an impact, drive progress and create a better tomorrow. Our strategy…
Skills: Electrical Fault Finding, Mechanical Fault Finding, PLC Programming, GMP Compliance, Preventative Maintenance
Rockford, Illinois, United States · On-site
$24/hr–$29/hr
Life changing therapies. Global impact. Bridge to thousands of biopharma companies and their patients. We are PCI. Our investment is in People who make an impact, drive progress and create a better tomorrow. Our strategy…
Skills: Maintenance, Troubleshooting, Preventive Maintenance, Problem Solving, Collaboration
Rockford, Illinois, United States · On-site
$19/hr–$22/hr
Life changing therapies. Global impact. Bridge to thousands of biopharma companies and their patients. We are PCI. Our investment is in People who make an impact, drive progress and create a better tomorrow. Our strategy…
Skills: Inventory management, Quality control, Warehouse operations, Data entry, JDE system
Rockford, Illinois, United States · On-site
$24/hr–$29/hr
Life changing therapies. Global impact. Bridge to thousands of biopharma companies and their patients. We are PCI. Our investment is in People who make an impact, drive progress and create a better tomorrow. Our strategy…
Skills: Equipment maintenance, Troubleshooting, Preventive maintenance, Packaging lines, Changeovers
Madison, Wisconsin, United States · On-site
Life changing therapies. Global impact. Bridge to thousands of biopharma companies and their patients. We are PCI. Our investment is in People who make an impact, drive progress and create a better tomorrow. Our strategy…
Skills: Aseptic Techniques, cGMP, Fill Finish, Equipment Troubleshooting, Personnel Leadership
San Diego, California, United States · On-site
$151k–$170k/yr
Life changing therapies. Global impact. Bridge to thousands of biopharma companies and their patients. We are PCI. Our investment is in People who make an impact, drive progress and create a better tomorrow. Our strategy…
Skills: Account management, Salesforce, Business development, Sales planning, Negotiation
Philadelphia, Pennsylvania, United States · On-site
Life changing therapies. Global impact. Bridge to thousands of biopharma companies and their patients. We are PCI. Our investment is in People who make an impact, drive progress and create a better tomorrow. Our strategy…
Skills: Quality management, Project management, Personnel development, cGMP compliance, Regulatory compliance
Rockford, Illinois, United States · On-site
$18/hr–$20/hr
Life changing therapies. Global impact. Bridge to thousands of biopharma companies and their patients. We are PCI. Our investment is in People who make an impact, drive progress and create a better tomorrow. Our strategy…
Skills: Quality assurance, Documentation review, Batch record management, Compliance, cGMP
Rockford, Illinois, United States · On-site
$19/hr–$22/hr
Life changing therapies. Global impact. Bridge to thousands of biopharma companies and their patients. We are PCI. Our investment is in People who make an impact, drive progress and create a better tomorrow. Our strategy…
Skills: Cleaning, Sanitization, Equipment maintenance, Safety protocols, Quality assurance
Stamullen, Leinster, Ireland · On-site
Life changing therapies. Global impact. Bridge to thousands of biopharma companies and their patients. We are PCI. Our investment is in People who make an impact, drive progress and create a better tomorrow. Our strategy…
Skills: Maintenance, Electrical systems, Mechanical systems, PLC programming, GMP
Stamullen, Leinster, Ireland · On-site
Life changing therapies. Global impact. Bridge to thousands of biopharma companies and their patients. We are PCI. Our investment is in People who make an impact, drive progress and create a better tomorrow. Our strategy…
Skills: Maintenance, Electrical systems, Mechanical systems, PLC programming, GMP
Rockford, Illinois, United States · On-site
$18/hr–$20/hr
Life changing therapies. Global impact. Bridge to thousands of biopharma companies and their patients. We are PCI. Our investment is in People who make an impact, drive progress and create a better tomorrow. Our strategy…
Skills: Quality control, Documentation review, Cgmp compliance, Batch records, Line clearance
Stamullen, Leinster, Ireland · On-site
Life changing therapies. Global impact. Bridge to thousands of biopharma companies and their patients. We are PCI. Our investment is in People who make an impact, drive progress and create a better tomorrow. Our strategy…
Skills: Maintenance, Electrical systems, Mechanical systems, PLC programming, GMP
Blanchardstown, Leinster, Ireland · On-site
Life changing therapies. Global impact. Bridge to thousands of biopharma companies and their patients. We are PCI. Our investment is in People who make an impact, drive progress and create a better tomorrow. Our strategy…
Skills: Warehouse Management, WMS, SAP, Inventory Management, Staff Training
Bridgend, Wales, United Kingdom · On-site
Life changing therapies. Global impact. Bridge to thousands of biopharma companies and their patients. We are PCI. Our investment is in People who make an impact, drive progress and create a better tomorrow. Our strategy…
Skills: Sales, Business development, Lead generation, Contract negotiation, CRM software
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The QA Specialist II is responsible for performing batch record reviews, lot disposition, and overseeing quality system events such as deviations and CAPAs. They will also provide QA expertise to support clinical and commercial manufacturing while ensuring compliance with cGMP and regulatory standards.
Candidates should have a Bachelor's degree in a scientific discipline and 5-7 years of pharmaceutical or biotech experience, including at least 3 years in a QA Operations role. Proficiency in FDA regulations, technical writing, and risk management tools is required.
Life changing therapies. Global impact. Bridge to thousands of biopharma companies and their patients.
We are PCI.
Our investment is in People who make an impact, drive progress and create a better tomorrow. Our strategy includes building teams across our global network to pioneer and shape the future of PCI.
Position Title: QA Specialist II Operations
Location: Bedford, New Hampshire
Department: Quality Assurance
Reporting To: QA Manager / QA Director
Responsible For (Staff): No
The QA Specialist II will work with other departments to ensure the quality of products and compliance to internal procedures and external standards. Primary responsibilities for this role includes Batch Record Review, Lot Disposition, and Quality System review. This position may also be responsible for evaluating deviation incidences and determining which warrant escalation to an investigation, quality review and approval of investigations, and creating and monitoring the associated CAPAs. In this role, the opportunity exists to shape and transform GxP programs by providing QA expertise and guidance to the manufacture of both clinical and commercial products
Perform review of batch documentation for release of internal and external clinical products/commercial products, while ensuring compliance with cGMPs, site SOPs, and regulatory requirements. Prioritize record review in support of business needs including maintaining batch status and communicate release needs throughout the organization
Review and approve master batch records for the timely initiation of GxP manufacturing activities
Responsible for quality oversight and administration of the deviation/investigation and CAPA programs
Review and approve Manufacturing, Quality Control, and other investigations in support of batch release and GMP compliance
Provide direction for complex investigations and CAPAs
Ensure timely, accurate and complete execution and documentation of quality system events: deviations, NCMRs, GxP investigations and CAPAs
Review, develop, and improve quality system procedures, specifications, and test methods
Review and approve CAPAs to prevent recurrence of deviations
Review and approve Change Control documentation
Responsible for tracking investigations and change control for timely completion. Provide status reports, including relevant quality metrics and participates in the management review process
Establish collaborative relationships with internal and external customers to ensure all quality and compliance matters and any issues that arise are addressed in an open and timely manner.
Monitor, identify and propose quality process and system improvements. Lead improvement projects and communicate status to management
Serve as QA representative to cross functional project teams such as tech transfer, process validation, and process improvement
Perform review of batch documentation for release of internal and external clinical products/commercial products, while ensuring compliance with cGMPs, site SOPs, and regulatory requirements. Prioritize record review in support of business needs including maintaining batch status and communicate release needs throughout the organization
Coordinate change control review meetings
Monitor status of change controls and facilitate the approval process
Perform risk assessments to comply with internal procedures and external guidelines
Provide training on department specific procedures and systems
Interface with clients to address any documentation and compliance concerns
Initiate, revise, and review controlled cGMP documents including SOPs, Material Specifications, Investigation protocols/reports, validation protocols/reports as applicable
Ensures site readiness for regulatory inspections
Bachelor’s Degree in a relevant scientific discipline preferred with a minimum of 5-7 years of pharmaceutical or biotech industry experience with 3+ years of experience in a QA Operations role supporting late stage clinical and/or commercial production
Experience performing RCA, technical writing, and working with quality related investigations
Knowledge of laboratory and production equipment and IQ/OQ/PQ
Knowledge of FDA regulations (i.e., 21CFR Part 210, 211 & 820) and some experience working with international regulations such as ICH
Experience using Risk Management Tools (FMEA, HACCP, PHA, etc.) and familiarity with ICH Q9
ASQ certification preferred Exceptional organizational skills and attention to detail
Ability to make risk based decisions and resolve issues with minimal guidance
Excellent interpersonal skills and the ability to communicate well orally and in writing
Proficiency in MS Office including Word, Excel, Access and Visio
Excellent verbal and written communication skills required
Ability to work in a dynamic, fast paced work environment
Honesty, integrity, respect and courtesy with all colleagues
Creative with the ability to work with minimal supervision and balanced with independent thinking
Resilient through operational and organizational change
Less than 10% travel.
This position may require additional hours and/or weekend work.
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Join us and be part of building the bridge between life changing therapies and patients. Let’s talk future
Equal Employment Opportunity (EEO) Statement:
PCI Pharma Services is an Equal Opportunity/Affirmative Action Employer. We do not unlawfully discriminate on the basis of race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, or any other protected status.
At PCI, Equity and Inclusion are at the core of our company’s purpose: Together, delivering life-changing therapies. We are committed to cultivating an inclusive workplace by holding ourselves accountable to the highest standards of understanding, fairness, respect, and equal opportunity – at every level. We envision a PCI community where everyone can belong and grow, and we strive to bring this vision to reality by continuously and intentionally assessing our people practices, policies and programs, marketing approach, and workplace culture.
CDMO. Inspired by tomorrow. Let's talk future™.
We are PCI Pharma Services. CDMO. Today’s Drug Development & Manufacturing, Advanced Drug Delivery & Drug Device Combination Products, Clinical Trial Services, and Commercial Packaging Technology. Inspired by tomorrow. We provide world-class solutions through intelligence, ingenuity and innovation, together, delivering life-changing therapies. Across 38 global sites and supported by more than 8,000 dedicated employees, we bring together leading technology and continued investment to deliver seamless solutions from development to commercialization, supporting our clients to improve the lives of patients worldwide.
Offices: 3001 Red Lion Rd, Philadelphia, PA 19114, US · 23 Commerce Dr, Bedford, New Hampshire 03110, US · 4545 Assembly Dr, Rockford, Illinois 61109, US · 6166 Nancy Ridge Dr, San Diego, California 92121, US · 977 Century Dr, Burlington, Ontario L7L 5J8, CA
CDMO. Inspired by tomorrow. Let's talk future™.
We are PCI Pharma Services. CDMO. Today’s Drug Development & Manufacturing, Advanced Drug Delivery & Drug Device Combination Products, Clinical Trial Services, and Commercial Packaging Technology. Inspired by tomorrow. We provide world-class solutions through intelligence, ingenuity and innovation, together, delivering life-changing therapies. Across 38 global sites and supported by more than 8,000 dedicated employees, we bring together leading technology and continued investment to deliver seamless solutions from development to commercialization, supporting our clients to improve the lives of patients worldwide.
Offices: 3001 Red Lion Rd, Philadelphia, PA 19114, US · 23 Commerce Dr, Bedford, New Hampshire 03110, US · 4545 Assembly Dr, Rockford, Illinois 61109, US · 6166 Nancy Ridge Dr, San Diego, California 92121, US · 977 Century Dr, Burlington, Ontario L7L 5J8, CA
