Quality Assurance Inspector

Catalent Pharma Solutions•Philadelphia, PA

22d•Onsite

About The Position

Quality Assurance Inspector Position Summary: Work Schedule: Monday – Friday, 8:00am – 4:30pm 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 and this position reports to the Quality Supervisor. The Quality Inspector is responsible for performing inspection and release of all components, clinical trial and commercial labels, drug products, distribution materials and paperwork as well as materials slated for destruction and associated paperwork, while ensuring SOPs and cGMP are being followed. The Quality Inspector will identify opportunities to improve the processes, raise these to Quality Management and assist in the implementation and improvement of these processes, in partnership with Supply Chain personnel, Project Management, and Operations. The Role Ensure adherence to SOPs and cGMPs during incoming inspection, distribution, label control, returns, and destruction activities, supporting both Commercial and Clinical Operations. Verify and inspect incoming materials and collaborate with Quality and Project Management to resolve discrepancies. Inspect and release clinical and commercial drug products and components per customer specifications and Catalent SOPs, including review of labels and receipt documentation. Inspect and release shipping and distribution materials by verifying paperwork, picked items, and randomized containers for protocol compliance. Inspect and release materials designated for destruction by reviewing associated documentation and materials. Inspect and release clinical labels (open, randomized, booklet, multilingual) by comparing to approved proofs or label copy requests. Review BMS and chart recorder printouts for temperature, humidity, and pressure deviations, and inspect retain samples as needed. Maintain and report departmental metrics and support walkthrough audits of Supply Chain areas for GMP compliance. Review facility, label room, pest control, and sampling logbooks for compliance; update SOPs as needed and support deviation investigations and process improvements. Perform additional sampling or testing as requested, participate in customer audits, complete required documentation, and support other tasks assigned by QA Management. All other duties as assigned The Candidate 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. 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.

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.
Strong analytical thinking and sound judgment.
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

Proficient computer skills; experience with MS Office and inventory management systems is a plus.

Responsibilities

Ensure adherence to SOPs and cGMPs during incoming inspection, distribution, label control, returns, and destruction activities, supporting both Commercial and Clinical Operations.
Verify and inspect incoming materials and collaborate with Quality and Project Management to resolve discrepancies.
Inspect and release clinical and commercial drug products and components per customer specifications and Catalent SOPs, including review of labels and receipt documentation.
Inspect and release shipping and distribution materials by verifying paperwork, picked items, and randomized containers for protocol compliance.
Inspect and release materials designated for destruction by reviewing associated documentation and materials.
Inspect and release clinical labels (open, randomized, booklet, multilingual) by comparing to approved proofs or label copy requests.
Review BMS and chart recorder printouts for temperature, humidity, and pressure deviations, and inspect retain samples as needed.
Maintain and report departmental metrics and support walkthrough audits of Supply Chain areas for GMP compliance.
Review facility, label room, pest control, and sampling logbooks for compliance; update SOPs as needed and support deviation investigations and process improvements.
Perform additional sampling or testing as requested, participate in customer audits, complete required documentation, and support other tasks assigned by QA Management.
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
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