Quality Assurance Document Control

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

• Work Schedule: Monday 2 d3n22d Friday, 4:00pm-12:30am.
• 100% on-site

Catalent2 b22s 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 quality or manufacturing role within a regulated environment OR
• Associate2s 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

Why you should join Catalent

• 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

Catalent offers rewarding opportunities to further your career!

Join the global drug development and delivery leader and help us bring over 7,000 life-saving and life-enhancing products to patients around the world. Catalent is an exciting and growing international company where employees work directly with pharma, biopharma and consumer health companies of all sizes to advance new medicines from early development to clinical trials and to the market. Catalent produces more than 70 billion doses per year, and each one will be used by someone who is counting on us. Join us in making a difference.

personal initiative. dynamic pace. meaningful work.

Visit Catalent Careers to explore career opportunities.

Catalent is an Equal Opportunity Employer, including disability and veterans.

If you require reasonable accommodation for any part of the application or hiring process due to a disability, you may submit your request by sending an email, and confirming your request for an accommodation and include the job number, title and location to [e-mail]. This option is reserved for individuals who require accommodation due to a disability. Information received will be processed by a U.S. Catalent employee and then routed to a local recruiter who will provide assistance to ensure appropriate consideration in the application or hiring process.

Notice to Agency and Search Firm Representatives: Catalent Pharma Solutions (Catalent) is not accepting unsolicited resumes from agencies and/or search firms for this job posting. Resumes submitted to any Catalent employee by a third party agency and/or search firm without a valid written & signed search agreement, will become the sole property of Catalent. No fee will be paid if a candidate is hired for this position as a result of an unsolicited agency or search firm referral. Thank you.

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