Quality Assurance Inspector

About 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. Why you should join Catalent: 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 Catalent offers rewarding opportunities to further your career! Join the global drug development and delivery leader and help us bring over 7,000 life-saving and life-enhancing products to patients around the world. Catalent is an exciting and growing international company where employees work directly with pharma, biopharma and consumer health companies of all sizes to advance new medicines from early development to clinical trials and to the market. Catalent produces more than 70 billion doses per year, and e