Quality Assurance Specialist I

Catalent Pharma Solutions; Manassas (VA); On-site; USD 52,000 - 64,000; Full time

Benefits offered by this job

Medical benefits

Dental benefits

Vision benefits

Tuition reimbursement

PTO & holidays

WellBeing program

Job summary

Catalent Pharma Solutions seeks a Quality Assurance Specialist I in Manassas, VA to audit production lines, verify compliance with SQF, HACCP, and FQP standards, and communicate deviations. This 100% onsite role supports QA activities and cross-functional teams to maintain quality and regulatory standards.

The position emphasizes attention to detail, adherence to GMP, and ongoing training for quality control, with a shift from 10pm to 6:30am, on-site and in a dynamic consumer health

Qualifications

• Ability to communicate effectively in English, both verbally and in writing.
• High School Diploma required.
• Ability to communicate with all line-level positions and management.
• Strong attention to detail and accuracy.
• Self-starter with the ability to work independently.
• Ability to assert effectively when needed.
• Strong interpersonal skills to build cross-functional relationships.
• Strong analytical skills for quality assessment.
• Ability to read and follow SOPs and Test Methods.
• Knowledge of GMP and Quality systems.
• Physical capability to lift up to 50 pounds and perform necessary movements.
• Role involves standing/walking for ~85% of the time.
• Spanish language skills are a plus.

Responsibilities

• Conduct detailed quality audits of production lines to ensure standards.
• Verify equipment like metal detectors, x-ray machines, and scales.
• Audit operator paperwork for compliance with quality requirements.
• Report deviations with complete details to QA Supervisor.
• Identify housekeeping issues requiring attention and document non-conformities.
• Collaborate with Production and Packaging teams on daily issues.
• Enter and track results using computer systems.
• Ensure compliance with SQF, HACCP, and FQP standards.
• Maintain FDA and cGMP quality control practices, including training.
• Maintain Dietary Supplement identity, purity, strength and quality.
• Serve as alternate cover for QA Specialist II.
• Participate in required training and perform other duties.

Skills

English communication

Cross-functional communication

Attention to detail

Self-starter

Assertiveness

Interpersonal skills

Analytical skills

SOP reading

GMP knowledge

Physical ability

Mobility

Stamina

Spanish language

Education

High School Diploma

Bachelor of Science in Food Science

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.

Notice to Agency and Search Firm Representatives: Catalent Pharma Solutions (Catalent) is not accepting unsolicited resumes from agencies and/or search firms for this job posting. Resumes submitted to any Catalent employee by a third party agency and/or search firm without a valid written & signed search agreement, will become the sole property of Catalent. No fee will be paid if a candidate is hired for this position as a result of an unsolicited agency or search firm referral. Thank you.

Important Security Notice to U.S. Job Seekers:

Catalent NEVER asks candidates to provide any type of payment, bank details, photocopies of identification, social security number or other highly sensitive personal information during the offer process, and we NEVER do so via email or social media. If you receive any such request, DO NOT respond— it is a fraudulent request. Please forward such requests to [e-mail] for us to investigate with local authorities.

California Job Seekers can find our California Job Applicant Notice HERE.