Specialist - Client QA

Specialist, Client QA Role

About Site

Our FDA-licensed, state-of-the-art CGMP manufacturing facility for Gene Therapies is located on the Harmans/BWI campus. The campus, featuring two manufacturing facilities is located 5 miles from the Baltimore Washington International (BWI) airport and 13 miles from our Baltimore location. The campus is close to Washington, DC’s I-270 Technology Corridor, top universities, and government agencies.

The Harmans/BWI-1 EMA and FDA approved facility, at approximately 200,000 sq. ft., houses 10 CGMP manufacturing suites, fill/finish, central services, testing labs, and a warehouse.

The Harmans/BWI-2 facility, at approximately 145,000 sq. ft., is under development and will house 8 CGMP manufacturing suites and cold storage warehousing.

Both facilities support Phase 3 through commercial manufacturing of advanced therapeutic products including AAV and other viral vector-based therapies and vaccines.

Position Summary

We have an opportunity for a Specialist, Client QA to join our team and provide quality assurance support for client projects from start to finish. This role ensures oversight of GMP manufacturing for cell banks, bulk drug substances, and finished drug products. You will act as the dedicated Client QA Representative, collaborating with clients and internal teams across multiple functions. The position involves reviewing documentation, supporting investigations, and ensuring compliance to enable timely release of materials.

Shift: Monday – Friday 8am-5pm
Location: Harmans, MD - BWI
100% Onsite

The Role

• Serve as the primary point of contact for multiple clients at the site.
• Address client comments and concerns, attend meetings to provide updates, and manage client interactions as needed.
• Review deviations and change controls in the TrackWise system, working with technical subject matter experts to determine appropriate actions before approval.
• Act as the primary contact for client audits, providing back-room support and addressing project-specific questions when required.
• Participate in weekly QA-to-QA meetings and team updates with clients.
• Contribute to Master Batch Record review prior to batch execution.
• Adapt quickly to processes, work with established clients, and identify opportunities for improvement.
• Handle challenging situations, including making difficult decisions when necessary.

The Candidate

Minimum Requirements

• Master’s degree in a Scientific, Engineering, or Biotech field with 0–2 years of experience in Quality Assurance or Quality Control within biologics, biopharmaceuticals, or a regulated industry, OR
• Bachelor’s degree in a Scientific, Engineering, or Biotech field with 2–4 years of experience in Quality Assurance or Quality Control within biologics, biopharmaceuticals, or a regulated industry.
• Knowledge of Good Manufacturing Practices (GMPs), 21 CFR Parts 210 and 211, biological regulations per 21 CFR Parts 600s, ICH Guidelines, and EU GMPs.
• Creative individual with strong analytical, troubleshooting, and decision-making skills.
• Ability to quickly learn new and novel manufacturing processes supporting new clients.
• Capable of working in a team setting and independently with minimal supervision.
• Ability to deliver results in a fast-paced environment to meet client deadlines.

Preferred Skills & Background

• Knowledge and/or exposure to biological manufacturing processes including microbial and cell culture cell banking, fermentation/cell culture, purification, and fill/finish.
• Familiarity with electronic systems and experience developing and producing reports using Microsoft products. Knowledge of LIMS, Master Control, and TrackWise preferred.

Pay

The anticipated salary range for this position in MD is $70,000 – $90,000 Plus Bonus. The final salary offered to a successful candidate may vary, and will be dependent on several factors that may include but are not limited to: the type and length of experience within the job, type and length of experience within the industry, skillset, education, business needs, etc. Catalent is a multi-state employer, and this salary range may not reflect positions that work in other states.

Why You Should Join Catalent

• Defined career path and annual performance review and feedback process.
• Diverse, inclusive culture.
• Potential for career growth on an expanding team within an organization dedicated to preserving and bettering lives.
• Competitive paid time off plus 8 paid holidays.
• Community engagement and green initiatives.
• Medical, dental, and vision benefits effective day one of employment.
• Tuition reimbursement.

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.

Visit Catalent Careers to explore career opportunities.

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 DisabilityAccommodations@catalent.com. 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.

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