Document Control Specialist

Catalent Pharma Solutions LLC; Manassas (VA); On-site; USD 60,000 - 85,000; Full time

Benefits offered by this job

Competitive PTO

Medical, dental, vision benefits

Tuition Reimbursement

Employee engagement activities

Wellness program

Job summary

Catalent, Inc. is seeking a Quality Documentation Specialist to create and maintain Quality System documentation and ensure compliance with SQF, HACCP, and FQP standards. You will support the QA team on special projects and communicate deviations to management, contributing to ongoing improvements.

The role involves coordinating document routing, internal audits, and collaboration with Production, Packaging, and R&D to keep records up to date. Strong writing and attention to detail are essential.

Qualifications

• High School Diploma or GED with 3+ years of experience in the food industry.
• Knowledge of GMP and Quality systems.
• Experience reading and following SOPs and test methods.
• Proficiency with Microsoft Office applications (Excel, PowerPoint, Word).

Responsibilities

• Create and maintain documentation related to the Quality System with proper formatting, numbering, and organization of documents.
• Manage routing and approval for new documents and process deviations.
• Perform internal audits and document non-conformances to support CI efforts.
• Document all areas of non-compliance and ensure corrective actions are implemented.
• Collaborate with Production, Packaging Managers, Supervisors, and R&D to update records and documentation.
• Ensure compliance with SQF, HACCP, and FQP standards and FDA/cGMP requirements.
• Provide training and assist in continuous training initiatives.
• Review operators' paperwork to verify quality standards are met.

Skills

English communication

Attention to detail

Self-starter

Interpersonal skills

Analytical skills

SOP literacy

GMP knowledge

Microsoft Office

Education

High School Diploma / GED

BSc in Food Science (preferred)

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.

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 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.

Equal Opportunity Employer

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.

Corporate Overview

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.