What are the responsibilities and job description for the Quality Assurance Document Control Associate position at Catalent?
Quality Assurance Document Control
Position Summary:
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. It’s an excellent opportunity to build hands-on experience in a fast-paced GMP environment, contribute directly to product quality, and collaborate with leading pharmaceutical partners in a global setting.
The Role
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 DisabilityAccommodations@catalent.com. 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.
Important Security Notice to U.S. Job Seekers:
Catalent NEVER asks candidates to provide any type of payment, bank details, photocopies of identification, social security number or other highly sensitive personal information during the offer process, and we NEVER do so via email or social media. If you receive any such request, DO NOT respond— it is a fraudulent request. Please forward such requests to spam@catalent.com for us to investigate with local authorities.
California Job Seekers can find our California Job Applicant Notice HERE.
Position Summary:
- Work Schedule: Monday – Friday, 8:00am-4:30pm
- 100% on-site
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. It’s an excellent opportunity to build hands-on experience in a fast-paced GMP environment, contribute directly to product quality, and collaborate with leading pharmaceutical partners in a global setting.
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.
- 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.
- 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 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 multi-task
- 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
- Experience with inspections or batch record review strongly preferred
- Good organizational/time management skills and ability to multi-task
- 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
- 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
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 DisabilityAccommodations@catalent.com. 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.
Important Security Notice to U.S. Job Seekers:
Catalent NEVER asks candidates to provide any type of payment, bank details, photocopies of identification, social security number or other highly sensitive personal information during the offer process, and we NEVER do so via email or social media. If you receive any such request, DO NOT respond— it is a fraudulent request. Please forward such requests to spam@catalent.com for us to investigate with local authorities.
California Job Seekers can find our California Job Applicant Notice HERE.