Quality Documentation Specialist

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

Benefits offered by this job

Competitive PTO

Medical/Dental/Vision benefits

Tuition Reimbursement

Site-based engagement

Employee Resource Groups

WellHub program

Perkspot discounts

Job summary

Catalent in Manassas, VA is seeking a Quality Documentation Specialist to create and maintain Quality System documentation and support continuous improvement. This on-site role works with QA, Production, and R&D to ensure compliance with SQF, HACCP, and FDA cGMP standards.

The position emphasizes precise document control, audits, and cross-functional collaboration to uphold food safety and quality across the facility.

Qualifications

• Must be able to communicate effectively verbally and in written English.
• High School Diploma or GED with 3+ years in the food industry is required.
• Ability to communicate with all line-level positions and management.
• Attention to detail and self-starter attitude.
• Strong interpersonal and cross-functional collaboration skills.
• Ability to read and follow SOPs and Test Methods.
• Knowledge of GMP and Quality systems.
• Proficiency in Microsoft Office (Excel, PowerPoint, Word).

Responsibilities

• Create and maintain documentation for the Quality System (Master Manufacturing Records, specs, BPRs, Food Safety and Quality Plans).
• Manage routing and approval process for new documents and deviations.
• Perform internal audits and document non-conformances to support continuous improvement.
• Document all areas of non-compliance and ensure corrective actions.
• Collaborate with Production, Packaging, Supervisors, and R&D to update records and docs.
• Ensure compliance with SQF, HACCP, Food Quality Plans, FDA and cGMP standards.
• Enter and track results in computer systems and report deviations to QA leadership.
• Review operators' paperwork to ensure quality standards are met.

Skills

Communication skills

Attention to detail

Independent worker

Interpersonal skills

Analytical skills

SOP literacy

Education

High School Diploma or GED

Bachelor of Science in Food Science

Tools

Microsoft Office

Job description

About Site

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

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

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.

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 [e-mail] for us to investigate with local authorities.

California Job Seekers can find our California Job Applicant Notice HERE.

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.

Catalent, Inc. is a leading global contract development and manufacturing organization (CDMO) whose mission is to develop, manufacture, and supply products that help people live better and healthier lives. Catalent is dedicated to delivering unparalleled service to pharma, biotech, and consumer health customers, supporting product development, launch, and full life‑cycle supply. With time‑tested experience in development sciences, delivery technologies, and multi‑modality manufacturing, Catalent supports the acceleration of development programs and the launch of more than a hundred new products every year. Powered by thousands of scientists and technicians and the latest technology platforms at more than 40 global sites, Catalent supplies billions of doses of life‑enhancing and life‑saving treatments for patients annually.