Quality Assurance Document Control

1w1 week ago

Catalent Pharma Solutions

Philadelphia, US · Full-time · $60,000 – $85,000

About this role

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 Quality Assurance Document Control role is responsible for preparing customer files, reviewing and approving batch records, and releasing finished products. This position serves as the primary liaison with customer quality teams.

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 to align QA activities with operational priorities. Review completed batch records for accuracy, protocol adherence, and procedural compliance.

Works closely with operations, production, project management, shipping, and quality groups to ensure timely and compliant batch record review and release. Collaborate with cross-functional teams to resolve documentation issues and ensure compliance with regulations, procedures, and client requirements. Verify randomization schedules are correctly applied for patient treatment group assignments.

Join a diverse, inclusive culture with a positive working environment focused on continually improving processes. Potential for career growth on an expanding team dedicated to preserving and bettering lives. Defined career path and annual performance review and feedback process.

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
Associate’s degree with a minimum of 2 years of GMP experience in a quality or manufacturing role within a regulated environment
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, Word, 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

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
Generous 401K match
Medical, dental and vision benefits
Tuition Reimbursement