Quality Assurance Inspector

Catalent Pharma Solutions • Philadelphia, PA

5d • Onsite

About The Position

Catalent’s Philadelphia-area facility is 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 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 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.

Requirements

• High school diploma or GED with a minimum of 2 years 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.

Nice To Haves

• Bachelor’s degree preferred with a minimum of 1 year of quality or manufacturing experience within a GMP environment.

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

• 152 hours of PTO + 8 paid holidays
• Several Employee Resource Groups focusing on D&I
• Medical, dental and vision benefits
• Tuition Reimbursement
• WellHub- program to promote overall physical wellness
• Perkspot - offers exclusive or private discounts from approximately 900+ merchants in a wide array of categories
• Generous 401K match

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Education Level: High school or GED