Quality Assurance Supervisor
About The Position
Catalent’s 206,878-square-foot Philadelphia-area facility serves as the global Center of Excellence for Clinical Supply Packaging, offering GMP secondary packaging and clinical labeling services. The site provides manual to fully automated packaging solutions, including temperature-controlled options for sensitive products. The Quality Assurance department is responsible for ensuring compliance with quality system and product quality requirements defined by international regulations and corporate, network, and local standard operating procedures. The Quality Operations department supports this by providing oversight and guidance on matters affecting the quality system or product quality in daily operations.
Requirements
- HS Diploma/GED and 5+ years of Production QA experience required.
- 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 (e.g. Production, Validation, etc.)
- Good Computer Skills.
- Ability to be on feet and move easily throughout the Operations facilities.
- Ability to quickly learn and implement QA Auditing techniques.
- Individual may be required to sit, stand, walk regularly and occasionally lift 0-15 pounds.
- Be accessible to production floor, supply chain and office staff and to use required office equipment.
- Specific vision requirements include reading of written documents and use of computer monitor screen frequently.
Nice To Haves
- College degree preferred (BA, BS)
- Previous supervisory experience of 5 years or more preferred.
- 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.
- Knowledge reading engineering drawings/material specifications, a plus.
Responsibilities
- 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
Benefits
- Defined career path and annual performance review and feedback process
- Diverse, inclusive culture
- Positive working environment focusing on continually improving processes to remain innovative
- Potential for career growth on an expanding team within an organization dedicated to preserving and bettering lives
- 152 hours of PTO + 8 paid holidays
- Several Employee Resource Groups focusing on D&I
- Dynamic, fast-paced work environment
- Community engagement and green initiatives
- Generous 401K match
- Medical, dental and vision benefits
- Tuition Reimbursement - Let us help you finish your degree or start a new degree!
- WellHub- program to promote overall physical wellness
- Perkspot - offers exclusive or private discounts from approximately 900+ merchants in a wide array of categories
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
Education Level
High school or GED
