QA Document Control Specialist – Batch Records Liaison

Catalent; Philadelphia (Philadelphia County); On-site; USD 65,000 - 90,000; Full time

Benefits offered by this job

152 hours PTO + 8 holidays

Generous 401K match

Medical, dental and vision benefits

Tuition Reimbursement

Job summary

Catalent’s Philadelphia-area facility serves as a global Center of Excellence for Clinical Supply Packaging. The Quality Assurance Document Control role prepares customer files, reviews batch records, and releases finished products on-site.

Collaborate with operations, production, PM, shipping, and QA to ensure compliant reviews, with opportunities to work across teams and advance within a GMP-regulated environment.

Qualifications

• GMP experience in a quality or manufacturing role within a regulated environment.
• Experience with inspections or batch record review.
• Strong organizational and time management skills with ability to multitask.
• Advanced computer skills including Excel, Word, Outlook; SAP/JDE preferred.

Responsibilities

• Review and approve batch records before production to ensure compliance with cGMP and trial protocols.
• Monitor production schedules and plan QA activities accordingly.
• Review batch records for accuracy and protocol adherence.
• Verify randomization schedules for patient treatment groups.
• 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.

Skills

Organizational skills

Time management

Multitasking

Documentation

GMP experience

Education

High school diploma

Associate degree

BA/BS degree

Tools

Excel

Word

Outlook

Internet Explorer

SAP/JDE

Job description

Catalent’s Philadelphia-area facility serves as a global Center of Excellence for Clinical Supply Packaging. The Quality Assurance Document Control role prepares customer files, reviews batch records, and releases finished products on-site.

Collaborate with operations, production, PM, shipping, and QA to ensure compliant reviews, with opportunities to work across teams and advance within a GMP-regulated environment.