Quality Assurance Inspector, Production
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 Inspector is responsible for process monitoring and auditing of packaging operations, the duties including real-time batch documentation review, monitoring of adherence to cGMP, training on cGMP where necessary, and supporting actions (if required) for resolution of deviations and investigations.
Requirements
- High school diploma or GED with 2+ years of quality or manufacturing experience within a GMP environment required
- Proficient computer skills; experience with MS Office and inventory management systems is a plus.
- Comfortable being on your feet and moving between multiple warehouse areas.
- Ability to quickly learn and apply QA auditing techniques.
- Individual will be required to stand and/or sit for long periods of time, occasionally lift 0-25 pounds
- Willingness to work overtime, frequently in cold environments, and track, monitor and maintain production rates, labor hours and downtime.
Nice To Haves
- Bachelor’s degree with 1+ years of quality or manufacturing experience within a GMP environment preferred
- Proven track record of monitoring/auditing for quality assurance and/or identifying potential efficiencies in a production environment preferred.
Responsibilities
- Ensure SOPs and cGMP requirements are consistently followed during packaging operations, including real-time auditing and monitoring.
- Verify and reconcile materials before/after production and collaborate with Production, Materials Management, and Project Management to resolve discrepancies.
- Inspect and release packaging rooms, confirming proper cleaning and material clearance per GMP expectations.
- Document activities in applicable logbooks and review production logbooks and batch records for GMP and documentation accuracy.
- Support mechanics with Operational Verifications (OVs), equipment setup, and related records prior to and during packaging runs.
- Review Production and QA Protocols before job start and perform/document hourly QA inspections per SOP and protocol requirements.
- Monitor adherence to GMP standards during packaging and ensure batch documentation aligns with inventory system entries and printed labels.
- Review environmental monitoring outputs (temperature, humidity, pressure) and ensure clean storage rooms meet approval criteria.
- Conduct floor, warehouse, and clean storage walkthroughs to verify GMP compliance; document shift activities in QA turnover logs.
- Partner with cross-functional teams on deviations, investigations, and troubleshooting; support sampling/testing requests, equipment parts review, and customer audits.
- Performs other duties or tasks as requested or required by QA Management.
Benefits
- 152 hours of PTO + 8 paid holidays
- Several Employee Resource Groups focusing on D&I
- 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
Number of Employees
5,001-10,000 employees
