QA Inspector - 2nd Shift

Catalent Pharma Solutions•Philadelphia, PA

4d•Onsite

About The Position

Quality Assurance Inspector (Production) Position Summary Work Schedule: Monday – Friday, 3:45pm - 12:15am 100% on-site 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. Come and be part of a team that delivers industry-leading quality and innovation. Catalent Pharma Solutions in Philadelphia is hiring a Quality Assurance Inspector, Production and this position reports to the Quality Supervisor. 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. The scope of work will cover packaging room and equipment set up, equipment verification, routine packaging operations, line clearances, room and equipment cleaning activities. The Quality Inspector will identify opportunities to improve the ‘right-first-time’ performance of the operation and will manage those opportunities to implementation and improvement, in partnership with Production personnel. The Role 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.

Requirements

High school diploma or GED with a minimum of 2 years of quality or manufacturing experience within a GMP environment; Bachelor’s degree preferred with a minimum of 1 year of quality or manufacturing experience within a GMP environment.
Strong written and verbal communication skills.
Effective interpersonal skills and ability to work collaboratively in a team environment.
Proficient computer skills; experience with MS Office and inventory management systems is a plus.
Strong analytical thinking and sound judgment and has the ability to thrive in a dynamic environment with shifting priorities.
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

Proven track record of monitoring/auditing for quality assurance and/or identifying potential efficiencies in a production environment preferred.
Proficient computer skills; experience with MS Office and inventory management systems is a plus.

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

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
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