Quality Assurance Specialist I

Catalent; Manassas (VA); On-site; USD 52,000 - 68,000; Full time

Benefits offered by this job

Medical, dental, and vision benefits

Benefits on day one

Tuition reimbursement

Paid time off + holidays

Job summary

Catalent in Manassas, VA is seeking a Quality Assurance Specialist I to audit production lines, verify equipment, and ensure adherence to SQF, HACCP and FQP standards. This role also serves as alternate cover for QA Specialist II and involves 100% onsite night shift.

You will document deviations, report to QA Supervisor, collaborate with Production and Packaging teams, and maintain FDA/cGMP compliance while supporting dietary supplement quality.

Qualifications

• Must be able to communicate effectively in English, both verbally and in writing.
• High School Diploma (minimum) and ability to read SOPs and Test Methods.
• GMP and Quality systems knowledge.
• Ability to lift up to 50 pounds.
• Detail-oriented with strong analytical skills.

Responsibilities

• Conduct detailed quality audits of production lines to ensure products meet standards.
• Verify equipment such as metal detectors, x-ray machines, and scales.
• Audit operator paperwork for compliance with quality requirements.
• Report deviations to QA Supervisor with complete details.
• Identify and report housekeeping issues requiring attention.
• Document non-compliance areas and ensure corrective actions are implemented.
• Collaborate with Production and Packaging Managers and associates on daily issues.
• Enter and track result data using computer systems.

Skills

English communication

Attention to detail

Independent work

Cross-functional teamwork

Analytical skills

SOP literacy

Education

Bachelor of Science in Food Science or related major

Job description

About Site

The :70,000‑square‑foot Manassas facility operates within Catalent’s Consumer Health portfolio, supporting programs from early development through commercial manufacturing and packaging. It is designed for dietary supplement and food‑safety cGMP operations, making it distinct from Catalent’s traditional pharmaceutical and biologics manufacturing sites.

Position Summary

We have an opportunity for a Quality Assurance Specialist I to join our team. In this role, you will audit products and processes during production and packaging to ensure compliance with quality standards. You will communicate deviations, assist with special projects, and maintain adherence to SQF, Food Safety Plan (HACCP), and Food Quality Plan (FQP) standards. This position also serves as alternate cover for QA Specialist II.

Shift: 10pm-6:30am Monday to Friday

Location: Manassas, VA

100% Onsite

The Role

• Conduct detailed quality audits of production lines to ensure products meet established standards
• Verify equipment such as metal detectors, x-ray machines, and scales
• Audit operator paperwork for compliance with quality requirements
• Report deviations to the QA Supervisor with complete details
• Identify and report housekeeping issues requiring attention
• Document non-compliance areas and ensure corrective actions are implemented
• Collaborate with Production and Packaging Managers, Supervisors, and associates on daily issues
• Enter and track result data using computer systems
• Comply with SQF, Food Safety Plan (HACCP), and Food Quality Plan (FQP) standards
• Ensure compliance with FDA and cGMP standards for Quality Control, including ongoing training
• Maintain Dietary Supplement’s Identity, Purity, Strength, and Quality
• Serve as alternate cover for QA Specialist II
• Participate in all required training to perform job responsibilities
• Perform other duties as assigned

Minimum Requirements

• Ability to communicate effectively in English, both verbally and in writing
• High School Diploma
• Ability to communicate with all line-level positions and management
• Strong attention to detail
• Self-starter with ability to work independently with minimal supervision
• Ability to assert effectively when needed
• Strong interpersonal skills to build cross-functional and multinational relationships
• Strong analytical skills
• Ability to read and follow Standard Operating Procedures and Test Methods
• Knowledge of Good Manufacturing Practices (GMP) and Quality systems
• Must be able to lift and/or move up to 50 pounds
• Frequent standing, walking, reaching, stooping, kneeling, crouching, or crawling; occasional sitting, climbing, balancing, tasting, or smelling
• Approximately 85% of the role involves walking and standing

Preferred Skills & Background

• Knowledge of spoken Spanish is a plus
• Bachelor of Science in Food Science or related major is preferred

Why You Should Join Catalent

• Positive and fast-paced working environment focused on continuous improvement and innovation
• Competitive Paid Time Off plus 8 paid holidays
• Medical, dental, and vision benefits effective on day one
• Tuition Reimbursement to support your educational goals
• Engaging site activities such as potlucks, cookouts, and monthly birthday recognitions
• Employee Resource Groups promoting diversity and inclusion
• Environmentally friendly initiatives and community engagement programs
• Defined career path with annual performance reviews and growth opportunities
• WellHub program for physical and mental wellness
• Perkspot discounts from over 900 merchants across various categories

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.

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 [e-mail]. 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.