Quality Documentation Specialist

Catalent

1d • Onsite

About The Position

Quality Documentation Specialist
Position Summary
100% based on-site in Manassas, VA
Work Schedule: Regular business hours, Monday to Friday
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 Quality Documentation Specialist is responsible for creation and maintenance of the Quality System documentation. Communicate any deviations to management. The Quality Documentation Specialist will assist the Quality Assurance team with special projects as required. Comply with SQF, Food Safety Plan (HACCP), Food Quality Plan (FQP) standards.

Requirements

• HS Diploma or GED required
• 2+ years of experience working with documentation or quality systems required
• 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
• 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.

Nice To Haves

• Bachelor's degree in Food Science, Engineering, or technical major is preferred
• PCQI or HACCP experience is preferred
• Knowledge of spoken Spanish is a plus

Responsibilities

• 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.

Benefits

• 152 hours of PTO + 8 paid holidays

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Education Level: High school or GED