Catalent · 21 hours ago
Quality Assurance Document Control Associate
Philadelphia, PA
Full-time
Onsite
Entry, Mid Level
1+ years expCatalent is a global leader in drug development and delivery, known for its 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 collaborating with various teams to ensure compliance and quality in a fast-paced GMP environment.
BiotechnologyHealth CareManufacturingPharmaceutical
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
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
Qualification
Required
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
Good organizational/time management skills and ability to multi-task
Challenges status quo and initiates improvements
Preferred
Experience with inspections or batch record review strongly preferred
Advanced computer skills – including a high level of proficiency in Microsoft Office including Excel, Work, Outlook, IE, SAP/JDE preferred
Benefits
152 hours of PTO + 8 paid holidays
Generous 401K match
Medical, dental and vision benefits
Tuition Reimbursement - Let us help you finish your degree or start a new degree!
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Company
Catalent
Catalent - Blow-Fill-Seal Sterile CDMO Business is focusing on complex clinical to commercial stage formulation and manufacturing. It is a sub-organization of Catalent Pharma Solutions.
10001+ employees
H1B Sponsorship
Catalent has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2022 (1)
Funding
Current Stage
Late StageTotal Funding
unknown2021-01-06Acquired
Leadership Team
Alessandro Maselli
President & Chief Executive Officer
Charles Lickfold
Senior Vice President, Chief Information Officer
Recent News
2026-01-22
Company data provided by crunchbase