Document Control Specialist

Document Control Specialist

Position Summary

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.

Our Manassas, Virginia site is a part of the Consumer Health division and provides expanded capabilities in soft chews and lozenges. With extensive development and manufacturing expertise and a wide range of flavors, ingredients, and colors available, we can work with complex formulations to help create engaging new products consumers will love.

The Document Control Specialist is responsible for creation and maintenance of the Quality System documentation. Communicate any deviations to management. The Document Control Specialist will assist the Quality Assurance team with special projects as required. Comply with SQF, Food Safety Plan (HACCP), Food Quality Plan (FQP) standards.

The Role

• Create, revise, and maintain all documentation related to the Quality System using technical writing best practices, ensuring proper formatting, numbering, and document control.

• Issue batch records to Production and Packaging departments in a timely and accurate manner.

• Review and sign off on completed batch production records to verify compliance with internal and regulatory requirements.

• Support third-party certifications and customer audits by preparing documentation and assisting on-site as needed.

• Manage the routing, review, and approval processes for controlled documents, deviations, change controls, and other QMS-related records.

• Perform internal audits to assess compliance with Quality System standards; document and report all findings and non-conformances.

• Collaborate in cross-functional meetings during New Product Introductions (NPIs) and Change Control processes.

• Track and document all areas of non-compliance and assist in the implementation and verification of corrective and preventive actions (CAPAs).

• Work closely with Production, Packaging, R&D, and other departments to maintain and update records, specifications, and process documents.

• Other duties as assigned.

The Candidate

• Bachelor's degree in Food Science, Engineering, or technical major is preferred

• HS Diploma or GED required

• PCQI or HACCP experience is preferred

• 2+ years of experience working with documentation or quality systems required

• Strong analytical skills

• Ability to read and follow documents (Standard Operating Procedures and Test Methods)

• Knowledge of GMP and Quality systems

• Previous experience in Excel and Microsoft Office

•  Knowledge of spoken Spanish is a plus

• The employee must be able to lift and/or move up to 50 pounds. While performing the duties of this job, the employee is required to use hands to finger, handle, or feel and is frequently required to stand, walk, reach with hands and arms, stoop, kneel, crouch, or crawl, and talk or hear.

• The employee is required to sit, climb or balance and taste or smell.

Why You Should Work At Catalent

• Spearhead exciting and innovative projects

• Fast-paced, dynamic environment

• High visibility to members at all levels of the organization

• 152 hours of PTO + 8 paid holidays

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.

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