About this Quality Documentation Specialist role at Catalent
About Site
The ~70,000‑square‑foot Manassas facility operates within Catalent’s Consumer Health portfolio, supporting programs from early development through commercial manufacturing and packaging. It is designed for dietary supplement and food‑safety cGMP operations, making it distinct from Catalent’s traditional pharmaceutical and biologics manufacturing sites.
Position Summary
We have an opportunity for a Quality Documentation Specialist to join our team. In this role, you will be responsible for creating and maintaining Quality System documentation and ensuring compliance with industry standards. You will support the Quality Assurance team with special projects and communicate any deviations to management. This position plays a key role in maintaining food safety and quality standards across the site.
Shift: 9am-5:30pm Mon to Fri
Location: Manassas, VA
100% Onsite
The Role
Create and maintain documentation related to the Quality System using technical writing skills to ensure proper formatting, numbering, and organization of documents such as Master Manufacturing Records, specifications, Batch Production Records, Food Safety and Quality Plans, and other required documents.
Manage the routing and approval process for new documents and process deviations.
Perform internal audits and document all non-conformance to support continuous improvement efforts.
Document all areas of non-compliance with the Quality System and ensure corrective actions are implemented.
Work with Production and Packaging Managers, Supervisors, and Research & Development to maintain and update records and documentation.
Comply with SQF, Food Safety Plan (Hazard Analysis and Critical Control Points), and Food Quality Plan standards.
Ensure compliance with Food and Drug Administration and current Good Manufacturing Practice standards for Quality Control, including continuous training.
Ensure Dietary Supplement’s Identity, Purity, Strength, and Quality.
Document all areas of non-compliance and ensure corrective actions are completed. Use computer systems to enter and track result data.
Report any deviations to the Quality Systems and Regulatory Manager in complete, appropriate detail.
Review and verify operators' paperwork to ensure they meet quality standards.
Participate in all necessary training required to perform job responsibilities successfully.
Other duties as assigned.
The Candidate
Minimum Requirements
Must be able to communicate effectively verbally and in written English.
High School Diploma or General Educational Development, with 3+ years of experience in the food industry is required.
Ability to communicate with all line-level positions and management.
Attention to detail.
Self-starter and able to work independently with minimum supervision.
Able to assert themself effectively.
Strong interpersonal skills with the ability to develop cross-functional and multinational relationships to support interaction with various internal customers.
Strong analytical skills.
Ability to read and follow documents such as Standard Operating Procedures and Test Methods.
Knowledge of Good Manufacturing Practice and Quality systems.
Basic Microsoft Office skills (Excel, PowerPoint, and Word).
Must be able to lift and move up to 50 pounds and perform physical activities such as standing, walking, reaching, stooping, kneeling, crouching, crawling, and climbing. Frequent use of hands and ability to talk or hear is required. May also need to taste or smell.
Preferred Skills & Background
Bachelor of Science in Food Science or a related major is preferred.
Knowledge of spoken Spanish is a plus.
Why You Should Join Catalent
Positive and fast-paced working environment focusing on continually improving processes to remain innovative and dynamic.
Competitive Paid Time Off plus 8 paid holidays.
Medical, dental, and vision benefits effective day one of employment.
Tuition Reimbursement – support to finish your degree or earn a new one.
Site-based Employee Engagement activities such as potlucks, cookouts, and monthly birthday recognitions.
Employee Resource Groups focusing on Diversity and Inclusion.
Environmentally friendly, community engagement green initiatives.
Defined career path and annual performance review process with potential for career growth on an expanding team.
WellHub program to promote overall physical and mental wellness.
Perkspot – exclusive discounts from over 900 merchants in various 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 [email protected]. 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 [email protected] for us to investigate with local authorities.
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Volunteer Work Disclosure: Applicants for employment in Massachusetts may include in their employment history any verified work performed on a volunteer basis.
Massachusetts Lie Detector Test Notice: It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law may be subject to criminal penalties and civil liability. Consistent with Massachusetts law, Catalent does not require or administer lie detector tests as a condition of employment or continued employment.
