QualityAssuranceDocumentControl

**Quality Assurance Document Control** **Position Summary** * **Work Schedule: Monday – Friday, 4:00pm-12:30am.** * **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. **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. * Other tasks or projects as assigned. **The Candidate** * High school diploma or GED with a minimum of 5 years of GMP experience in a qual