Quality Assurance Supervisor
Catalent Pharma Solutions
Summary
Work schedule: M-F 8am-5pm 100% based on-site in Philadelphia, PA. Catalent's Philadelphia-area facility serves as the global Center of Excellence for Clinical Supply Packaging, offering GMP secondary packaging and clinical labeling services.
Job description
Position Summary
Work schedule: M-F 8am-5pm 100% based on-site in Philadelphia, PA. Catalent's Philadelphia-area facility serves as the global Center of Excellence for Clinical Supply Packaging, offering GMP secondary packaging and clinical labeling services.
The Role
- Responsible for all QA activities related to incoming, distribution and destruction and process auditing
- Assist in ensuring the quality and identity of pharmaceutical products during all aspects of the incoming, distribution, or packaging processes
- Act as the Quality partner to support the Supply Chain and Operations department
- Enforce Catalent policy and regulatory requirements
- Act as site subject matter expert for 'Good Manufacturing Practices' and 'Good Distribution Practices'
- Work to schedule a daily resource plan to support Supply Chain/Operations activities
- Act as lead investigator for all compliance issues regarding incoming, distribution, returns, destruction, or packaging/production
- Develop process excellence and efficiencies prior to the beginning of a project
- Track and report metrics and identify trends and predictive models
- All other duties as assigned
The Candidate
- HS Diploma/GED and 5+ years of Production QA experience required
- College degree preferred (BA, BS)
- Proven track record of monitoring/auditing quality and identifying potential efficiencies in a production environment
- Previous supervisory experience of 5 years or more preferred
- Experience in a regulated field – pharma, food, automotive, etc.
- Experience working on continuous improvement activities in partnership with other functions (e.g. Production, Validation, etc.)
- Good Computer Skills. Knowledge of MS Office and Inventory Management system are a plus
- Basic knowledge of Lean Six Sigma methodologies an advantage
- Good knowledge of the application of FDA cGMP's
- Ability to be on feet and move easily throughout the Operations facilities
- Ability to quickly learn and implement QA Auditing techniques
- Knowledge reading engineering drawings/material specifications, a plus
Requirements
- HS Diploma/GED
- 5+ years of Production QA experience
- Proven track record of monitoring/auditing quality and identifying potential efficiencies in a production environment
- Experience in a regulated field – pharma, food, automotive, etc.
- Experience working on continuous improvement activities in partnership with other functions
- Good Computer Skills
- Good knowledge of the application of FDA cGMP's
- Ability to be on feet and move easily throughout the Operations facilities
- Ability to quickly learn and implement QA Auditing techniques
Benefits
- 401(k) Matching
- Medical, Dental & Vision
- Tuition Reimbursement
- 152 hours PTO
- 8 Paid Holidays
- Employee Resource Groups
- Wellness Program
- Employee Discounts
Company overview
Catalent Pharma Solutions, now known as Catalent, Inc., is a leading global contract development and manufacturing organization (CDMO) headquartered in Tampa, Florida. Founded in 2007 as a spin-off from Cardinal Health's pharmaceutical technologies segment, the company has grown into a major player in the pharmaceutical services industry. Catalent provides comprehensive drug development and manufacturing solutions including drug delivery technologies, formulation development, analytical testing, clinical and commercial manufacturing, clinical packaging, and supply chain services. The company operates over 50 facilities across four continents and has supported more than half of all FDA-approved products over the past decade. With approximately 16,900 employees, Catalent produces over 70 billion doses annually for more than 8,000 products, serving major pharmaceutical companies like Pfizer, Moderna, Novo Nordisk, and Bristol-Myers Squibb. In 2024, the company was acquired by Novo Holdings A/S for $16.5 billion, further strengthening its position in the global pharmaceutical manufacturing landscape.