Quality Assurance Document Control Associate

Quality Assurance Document Control

Position Summary:

• Work Schedule:
  Monday - Friday, 3:45pm to 12:15am
• 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.

The Quality Assurance Document Control role is responsible for preparing customer files, reviewing and approving batch records, and releasing finished products while serving as the primary liaison with customer quality teams. This position works closely with operations, production, project management, shipping, and quality groups to ensure timely and compliant batch record review and release. It's an excellent opportunity to build hands-on experience in a fast-paced GMP environment, contribute directly to product quality, and collaborate with leading pharmaceutical partners in a global setting.

The Role

• Review and approve batch records before production to ensure compliance with cGMP, clinical trial protocols, and blinding requirements.
• Monitor production schedules and attend planning meetings as needed to align QA activities with operational priorities.
• Review completed batch records for accuracy, protocol adherence, and procedural compliance.
• Verify randomization schedules are correctly applied for patient treatment group assignments.
• Serve as the primary liaison with clients for batch record review and release.
• Collaborate with cross-functional teams to resolve documentation issues and ensure compliance with regulations, procedures, and client requirements.
• Ensure timely batch release to meet protocol initiation dates and update scheduling and inventory systems (e.g., JDE).
• Record, track, and analyze documentation errors to maintain and improve departmental quality metrics.
• Support and coach new QA Document Control staff while promoting a positive, safety-focused work environment.
• Maintain organized document archives and ensure compliance with EH&S, 5S, and quality system requirements.
• Other tasks or projects as assigned.

The Candidate

• High school diploma or GED with a minimum of 5 years of GMP experience in a quality or manufacturing role within a regulated environment OR
• Associate's degree with a minimum of 2 years of GMP experience in a quality or manufacturing role within a regulated environment OR
• BA/BS degree in a scientific or engineering discipline with a minimum of 1 year of GMP experience in a quality or manufacturing role within a regulated environment.
• Experience with inspections or batch record review strongly preferred
• Good organizational/time management skills and ability to multi-task
• Challenges status quo and initiates improvements
• Advanced computer skills - including a high level of proficiency in Microsoft Office including Excel, Work, Outlook, IE, SAP/JDE preferred

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!
• Well Hub- 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 Disabili This option is reserved for individuals who require accommodation due to a disability. Information received will be…