Quality Systems & Documentation Specialist

Catalent Pharma Solutions; Manassas (VA); On-site; USD 55,000 - 75,000; Full time

Benefits offered by this job

Competitive PTO

Medical/Dental/Vision benefits

Tuition Reimbursement

Site-based engagement

Employee Resource Groups

WellHub program

Perkspot discounts

Job summary

Catalent in Manassas, VA is seeking a Quality Documentation Specialist to create and maintain Quality System documentation and support continuous improvement. This on-site role works with QA, Production, and R&D to ensure compliance with SQF, HACCP, and FDA cGMP standards.

The position emphasizes precise document control, audits, and cross-functional collaboration to uphold food safety and quality across the facility.

Qualifications

• Must be able to communicate effectively verbally and in written English.
• High School Diploma or GED with 3+ years in the food industry is required.
• Ability to communicate with all line-level positions and management.
• Attention to detail and self-starter attitude.
• Strong interpersonal and cross-functional collaboration skills.
• Ability to read and follow SOPs and Test Methods.
• Knowledge of GMP and Quality systems.
• Proficiency in Microsoft Office (Excel, PowerPoint, Word).

Responsibilities

• Create and maintain documentation for the Quality System (Master Manufacturing Records, specs, BPRs, Food Safety and Quality Plans).
• Manage routing and approval process for new documents and deviations.
• Perform internal audits and document non-conformances to support continuous improvement.
• Document all areas of non-compliance and ensure corrective actions.
• Collaborate with Production, Packaging, Supervisors, and R&D to update records and docs.
• Ensure compliance with SQF, HACCP, Food Quality Plans, FDA and cGMP standards.
• Enter and track results in computer systems and report deviations to QA leadership.
• Review operators' paperwork to ensure quality standards are met.

Skills

Communication skills

Attention to detail

Independent worker

Interpersonal skills

Analytical skills

SOP literacy

Education

High School Diploma or GED

Bachelor of Science in Food Science

Tools

Microsoft Office

Job description

Catalent in Manassas, VA is seeking a Quality Documentation Specialist to create and maintain Quality System documentation and support continuous improvement. This on-site role works with QA, Production, and R&D to ensure compliance with SQF, HACCP, and FDA cGMP standards.

The position emphasizes precise document control, audits, and cross-functional collaboration to uphold food safety and quality across the facility.