Quality Assurance Inspector, Production
Position Summary
Work Schedule: 1st shift, Monday ā Friday, 7:45am - 4:15pm
100% on-site
Catalentās 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 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.
The Candidate
High school diploma or GED with 2+ years of quality or manufacturing experience within a GMP environment required
Bachelorās 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.
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.
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!Ā 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 each one will be used by someone who is counting on us. Join us in making a difference.Ā
personal initiative. dynamic pace. meaningful work.
Visit Catalent Careers to explore career opportunities.
Catalent is an Equal Opportunity Employer, including disability and veterans.
If you require reasonable accommodation for any part of the application or hiring process due to a disability, you may submit your request by sending an email, and confirming your request for an accommodation and include the job number, title and location to DisabilityAccommodations@catalent.com. This option is reserved for individuals who require accommodation due to a disability. Information received will be processed by a U.S. Catalent employee and then routed to a local recruiter who will provide assistance to ensure appropriate consideration in the application or hiring process.
Notice to Agency and Search Firm Representatives: Catalent Pharma Solutions (Catalent) is not accepting unsolicited resumes from agencies and/or search firms for this job posting. Resumes submitted to any Catalent employee by a third party agency and/or search firm without a valid written & signed search agreement, will become the sole property of Catalent. No fee will be paid if a candidate is hired for this position as a result of an unsolicited agency or search firm referral. Thank you.
Important Security Notice to U.S. Job Seekers:
Catalent NEVER asks candidates to provide any type of payment, bank details, photocopies of identification, social security number or other highly sensitive personal information during the offer process, and we NEVER do so via email or social media. If you receive any such request, DO NOT respondā it is a fraudulent request. Please forward such requests to spam@catalent.com for us to investigate with local authorities.
California Job Seekers can find our California Job Applicant Notice HERE.
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