Specialist - Client QA

About the role

The Specialist, Client QA role serves as the primary point of contact for multiple clients at the site. Addressing client comments and concerns, attending meetings to provide updates, and managing client interactions as needed are key responsibilities. This role also involves reviewing deviations and change controls in the TrackWise system, participating in QA-to-QA meetings, and contributing to Master Batch Record reviews.

Responsibilities

• 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.

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.
• Able to quickly learn new and novel manufacturing processes supporting new clients.
• Able to work in a team setting and independently with minimal supervision.
• Able to deliver results in a fast-paced environment to meet client deadlines.

Preferred Skills & Background

• Knowledge of 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.

Benefits

• 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.
• Medical, dental, and vision benefits effective day one of employment.
• Tuition reimbursement.

About Catalent

Catalent is a multi-state employer, and this salary range may not reflect positions that work in other states. 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. 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 spam@catalent.com for us to investigate with local authorities. California Job Seekers can find our California Job Applicant Notice HERE.