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: Analytical Chemistry, Quality Control, cGMP, HPLC, Karl Fischer
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: Quality Assurance, cGMP, GCP, Documentation Review, Data Analysis
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: Visual inspection, GMP standards, Good documentation practices, Attention to detail, Math skills
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: ERP Implementation, Project Management, Finance, SDLC, Waterfall
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: Change control management, Deviation handling, CAPA planning, Technical writing, Root cause analysis
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: Quality Assurance, cGMP Compliance, Documentation Review, Packaging Instructions, Batch Packaging Records
León, Castile and León, Spain · 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 manufacturing, cGMP compliance, Production equipment operation, Quality control, Documentation management
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: Quality Assurance, GMP, Batch Record Review, Visual Inspection, AQL
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: Project Management, Engineering, Capital Expenditure, New Product Introduction, Validation
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: Microbiology, Quality Control, cGMP, Environmental Monitoring, Aseptic Manufacturing
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 management, Inventory scheduling, Waste 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: Formulation Development, Analytical Testing, HPLC, UPLC, Biologics
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: Shipment processing, Data entry, JDE system, Proforma invoicing, Clinical distribution
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: Project management, GMP, FDA regulatory compliance, Clean utilities, Plant utilities
León, Castile and León, Spain · 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: Microbiological testing, GMP compliance, Environmental monitoring, Laboratory documentation, OOS investigation
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: Batch record review, Lot disposition, Quality system review, Deviation management, CAPA
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: Analytical Chemistry, Laboratory Testing, Technical Documentation, Laboratory Inventory Management, Sample Management
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: Manufacturing supervision, GMP compliance, Aseptic processing, Medical device manufacturing, Team leadership
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: Accounts receivable, Financial reporting, General ledger reconciliation, Collections strategy, Team leadership
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: Sterility Assurance, Industrial Microbiology, Aseptic Processing, Contamination Control Strategy, EU GMP Annex 1
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The QC Analytical Supervisor is responsible for overseeing laboratory activities, including peer review, procedure approval, and conducting OOS investigations. They also perform routine analytical testing, train staff, and ensure all laboratory documentation meets cGMP requirements.
Candidates must have a Bachelor of Science degree in a scientific field and at least 5 years of relevant analytical chemistry experience in a pharmaceutical manufacturing environment. Proficiency in cGMP laboratory practices and prior leadership experience are 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.
The QC Analytical Supervisor will have responsibility for supporting all activities in the Quality Control Laboratory including completing the majority of the peer review in the department and approving the majority of procedures used in the analytical department. The work includes the testing of in-process samples, finished product samples and raw materials. The QC Analytical Supervisor will communicate with clients regarding Out of Specification and other Quality System Events. The person in this position has knowledge of commonly-used analytic concepts, practices, and procedures within the field of his/her responsibilities. Also, must be familiar with cGMPs as they relate to analytical test methodologies and practices.
Essential Duties and Responsibilities: To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The essential duties and responsibilities include the following but other duties may be assigned.
Prioritize and distribute work to the analysts working in the QC Analytical laboratory
Conduct OOS and customer complaint investigations
Complete peer review of work executed within the analytical laboratory
Train new Employees
Routine Analytical testing of samples supporting incoming raw materials, in-process production and finished product testing
Performs analytical testing using HPLC, Karl Fischer, Particle Size Analyzer, UV Vis, Densitometer, Osmometer and other instrumentation as required
Perform instrument calibrations and preventative maintenance as needed
Documents laboratory work using laboratory worksheets/notebooks. Documentation must be detailed and meet CGMP requirements
Write, review and revise SOPs as required
Other duties as assigned or required
Special 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. The employee must be physically capable to perform the duties listed below with or without reasonable accommodations which may be made to enable individuals with disabilities to perform the essential functions.
Routine work requires walking, standing, bending, reaching, climbing stairs, lifting or carrying objects that typically weigh less than 50 lbs.
Capacity to work on several tasks simultaneously.
Able to organize and prioritize work activities.
Must be able to walk and drive between locations
Physically able to wear laboratory protective gowning and equipment, including but not limited to gowning, goggles, face shields, respirators, and protective gloves
Comfortable with working/handling of hazardous materials
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.
Works closely with Quality Assurance and Quality Control staff in performing varied work procedures and activities.
Interacts with Operations staff, Research and Development staff and clients on a regular basis.
Supervises the employees in the QC Analytical departmen
TRAVEL – <10%
Qualifications: The requirements listed below are representative of the knowledge, skill, and/or ability required for the stated position. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
5+ years relevant Analytical Chemistry experience, preferably in Quality Control, in a pharmaceutical manufacturing company
Experience working in a cGMP laboratory required
Experience working in a CMO (contact manufacturing/development organization) preferred
Prior leadership experience is preferred
Bachelor of Science in a scientific area of study
Master of Science in a scientific area of study and 3+ years Analytical Chemistry experience, preferably in Quality Control, in a pharmaceutical manufacturing company
Ability to prioritize tasks for staff
Ability to make informed decisions
Detail oriented
Strong oral and written communication skills
Excellent organization skills
Office Suite experience (Excel, Word, Access, and PowerPoint)Bachelor of Science in a scientific area of study
Excellent interpersonal skills and the ability to communicate well both orally and in in writing
Ability to multi-task in a dynamic environment with changing priorities
Resilient, can quickly move forward despite challenges
A drive to achieve results for self, and the team, and is cable of working with limited supervision
Positive attitude and strong team, cross team collaboration
Honesty, integrity, respect and courtesy with leadership and peers
Strong commitment to conducting PCI PHARMA SERVICES business according to the highest legal and ethical standards, and to continually pursue excellence in the manufacturing and delivery of PCI PHARMA SERVICES products and services
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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
