Quality Assurance Document Control

Catalent • Philadelphia, PA

2d • Onsite

About The Position

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. 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.

Requirements

• 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 with a minimum of 1 year of experience in a quality or manufacturing role within a GMP regulated environment
• Experience with inspections or batch record review strongly preferred
• Good organizational/time management skills and ability to multitask
• 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

Responsibilities

• 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.
• Other tasks or projects as assigned.

Benefits

• 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

What This Job Offers

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