Quality Documentation Specialist

Catalent Pharma Solutions • Manassas, VA

25d • Onsite

About The Position

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. 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.

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.

Nice To Haves

• Bachelor of Science in Food Science or a related major is preferred.
• Knowledge of spoken Spanish is a plus.

Responsibilities

• 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.

Benefits

• 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.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Education Level: High school or GED