Quality Documentation Specialist

Position Summary

100% based on-site in Manassas, VA.

Work Schedule:

Regular business hours, Monday to Friday.

• 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.

• Bachelor's degree in Food Science, Engineering, or technical major is preferred.
• HS Diploma or GED required.
• 2+ years of experience working with documentation or quality systems required.
• PCQI or HACCP experience is preferred.
• 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.

• 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.

Personal initiative. Dynamic pace. Meaningful work.

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Catalent is an Equal Opportunity Employer, including disability and veterans.