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: Document Control, cGMP, Quality Management System, eQMS, Batch Record Management
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
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The QA Specialist II manages and maintains cGMP documentation, procedures, and records to ensure compliance within the document control lifecycle. They facilitate workflows in electronic document management systems, perform batch record creation, and lead continuous improvement initiatives across departments.
Candidates must have a high school diploma and at least 10 years of industry experience, including a minimum of 6 years in document control within the biotech, pharmaceutical, or medical device sectors. Advanced knowledge of cGMPs, FDA regulations, and eQMS configuration 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 - Document Control
Location: Bedford, New Hampshire
Department: Quality Assurance, Document Control
Reporting To: Supervisor, Document Control
Responsible For (Staff): No
The individual will manage, coordinate, and maintain cGMP documentation, procedures, and records to ensure only controlled copies are reviewed, approved, issued, distributed, and archived. The Document Control QA Specialist II will evaluate document needs and participate in the processing of Documents and Records, maintain databases and Quality Management System tools and supports personnel and functional areas as needed. The primary objective of the Document Control QA Specialist II will be to contribute to the maintenance and improvement of the Document Control program and its systems. The QA Doc Control group is dedicated to the continuous improvement of the Document Change Control Lifecycle and Quality Systems to meet current compliance standards and ensure proper processing and release of controlled documents.
Maintain Quality System Master Documents and Master Document List
Facilitates workflows in the electronic document management system and legacy paper processes.
Performs the creation, modification, and approval of Client Batch Records independently.
Issues and reconciles batch records, testing data capture sheets, lab books, equipment log books, room log books, and Quality System event documents.
Maintains Document, Material and Batch numbering logs.
Writes and develops QA SOPs with minimal oversight.
Administers the maintenance of the Record/Document filing system at designated sites.
Proofs and edits document changes including minor SOP updates, as directed.
Participate in or lead audit preparation and reconciliation. Support audit requests. Perform internal audit tasks.
Supports metrics / report generation.
Cross-trains and provides support for coverage of multiple production facilities as needed. Covers absences.
Lead continuous improvement efforts and projects across the department, or multiple departments. Provide input, propose resolutions.
Performs obsolete and administrative document workflow within Master Control.
Leads Quality System Investigation and CAPA action items
Train others in doc control processes.
Develops and implements new tools and processes for Document Control with minimal oversight.
Participate in or facilitate functional area programs.
High School Diploma; and at least 10 years of industry experience with a minimum of 6 years document control experience in the Biotech, Pharmaceutical or Medical Device industries is required.
Previous Document Control and/or eQMS configuration and system management experience required.
Advanced knowledge of cGMPs, EU regulatory requirements, and FDA 21 CFR Parts 210,211 and 820 and Industry best practices required.
Working knowledge of Computer System Validation and Change Control requirements.
Assist is leading large or cross-functional projects and improvement initiatives as assigned.
Superior professional communication skills across all levels of the organization written and verbally
Superior customer service.
Identify and lead large or cross-functional projects and improvement initiatives.
May support more than one production facility.
Expert skill level in MS Office, general computer uses and the electronic Quality Management System and associated tools.
Excellent professional written and verbal skills. Team oriented.
Excellent Organizational skills. Highly Efficient.
Excellent attention to detail.
Perform repetitive tasks with high level of detail, requiring decision making on daily tasks and improvement initiatives. Sound decision making ability required. Recommend solutions to Management for critical decisions.
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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
