Quality Assurance Inspector

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.

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 each one will be used by someone who is counting on us. Join us in making a difference. 

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 respond— 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.