Document Control Specialist

Catalent Pharma Solutions; Manassas (VA); On-site; USD 55,000 - 75,000; Full time

Benefits offered by this job

PTO & holidays

Medical/dental/vision

Tuition reimbursement

Employee events

ERGs

Wellbeing program

Discount program

Job summary

Catalent’s Manassas site seeks a Quality Documentation Specialist to create and maintain Quality System documentation, ensuring SQF, HACCP, and FQP compliance. You will support the Quality Assurance team with special projects and communicate deviations to management, contributing to continuous improvement across operations.

This on-site role requires strong technical writing, attention to detail, and ability to work with Production, Packaging, and R&D teams to keep records accurate and up to

Qualifications

• Ability to communicate effectively in English (verbal and written).
• 3+ years of experience in the food industry with GMP knowledge.
• Ability to read and follow SOPs and Test Methods.
• Physically capable of lifting up to 50 pounds and performing onsite tasks.

Responsibilities

• Create and maintain documentation for the Quality System, ensuring proper formatting and organization.
• Manage routing and approval for new documents and deviations.
• Perform internal audits and document non-conformance for continuous improvement.
• Record non-compliance and ensure corrective actions are implemented.
• Collaborate with Production, Packaging, and R&D to update records and documentation.

Skills

Attention to detail

Self-starter

Analytical skills

MS Office

GMP knowledge

Education

High School Diploma or GED

BS in Food Science

Tools

Microsoft Office

Job description

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 SQF, Food Safety Plan (HACCP), and Food Quality Plan (FQP) standards. You will support the Quality Assurance team with special projects and communicate deviations to management. This position plays a key role in maintaining high-quality standards and continuous improvement within our operations.

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 all related documents, including MMRs, specifications, BPRs, 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 R&D to maintain and update records and documentation.
• Comply with SQF, Food Safety Plan (HACCP), and Food Quality Plan (FQP) standards.
• Ensure compliance with FDA and cGMP standards for Quality Control, including continuous training.
• Ensure Dietary Supplement’s Identity, Purity, Strength, and Quality.
• Participate in all necessary training required to perform job responsibilities successfully.
• Document all areas of non-compliance and ensure corrective actions are completed. Utilize the computer 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.
• Perform other duties as assigned.

The Candidate

Minimum Requirements

• Ability to communicate effectively verbally and in written English.
• High School Diploma or General Educational Development (GED) with 3+ years of experience in the food industry is required.
• Ability to communicate with all line-level positions and management.
• Strong attention to detail.
• Self-starter able to work independently with minimal supervision.
• Ability to assert oneself effectively.
• Strong interpersonal skills and ability to develop cross-functional and multinational relationships.
• Strong analytical skills.
• Ability to read and follow Standard Operating Procedures and Test Methods.
• Knowledge of Good Manufacturing Practices (GMP) and Quality systems.
• Basic proficiency in Microsoft Office (Excel, PowerPoint, and Word).
• The employee 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 talking or hearing. The employee may also be required to sit, climb, balance, and 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 Employee Potlucks, Company 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 and feedback process with potential for career growth.
• WellHub program promoting 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.

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.

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.