Quality Documentation Specialist

Catalent • Manassas, VA

15h • 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

• 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
• 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

Nice To Haves

• 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
• 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.

What This Job Offers

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