Quality Assurance Auditor - Analytical Review

Job Description

Catalent’s Greenville, North Carolina site is a major oral solid dose development and manufacturing campus, delivering end‑to‑end, turnkey solutions from formulation development through commercial manufacturing and packaging. The site specializes in oral solid dosage forms, supported by integrated formulation expertise, comprehensive analytical services, and scalable manufacturing capabilities designed to support both commercial products and potent or targeted therapies, including orphan drugs. Backed by more than $100 million in recent investments, the Greenville operation features fit‑for‑scale infrastructure, potent handling capabilities, and a strong regulatory track record, making it a critical part of Catalent’s global network for advancing complex oral drug programs from development to market.

Position Summary

We have an opportunity for a Quality Assurance Auditor – Analytical Review. This position requires the ability perform established routine and non-routine Quality Assurance tasks with minimal supervision in support of internal non-commercial clients, external clients and/or commercial processes and projects as assigned.

Shift: Monday- Friday 8:00am-5:00pm
Location: Greenville, NC
100% Onsite

The Role

• Ensure integrity of data through accurate transactions, documentation, and tracking of all cGMP activities

• Provide broad advocacy for the continued improvement of quality standards and the development and maintenance of a quality culture across the organization

• Work to create an environment of open communication, participation and information-sharing within and between teams within Quality Assurance and throughout the facility

• Support the development of a climate of quality and safety within the teams, by identifying and monitoring quality and safety standards

• Ensure compliance to all compendial, internal and client-specific requirements (i.e. SOPs, Quality Agreements, General and Informational Chapters in multiple compendia as applicable)

• Review/approve laboratory reports and COAs

• Review/approve stability reports (LWRs) in SLIM

• Release of Raw Materials in ERP System

• Ensure all work is performed and documented in accordance with approved standard operating procedures, in compliance with cGMPs

• Provide real time support for laboratories

• Other duties as assigned

The Candidate

Minimum Requirements

• Bachelor’s degree in a Life Sciences discipline with at least 3 years of professional experience in the pharmaceutical industry and at least 1 year in a direct QA role 

• Associate degree in a Life Sciences discipline with at least 2 years of professional experience in the pharmaceutical industry and at least 2 years in a direct QA role 

• Demonstrated ability to perform detailed analytical review of GMP documentation, laboratory data, batch records, protocols, reports, and quality records

• Position requires the capacity to handle and manipulate objects using hands and arms

Why You Should Join Catalent

• Positive and fast-paced working environment focusing on continual improvement and innovation.

• Competitive Paid Time Off plus 8 paid holidays.

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

• Tuition Reimbursement to help you finish your degree or earn a new one.

• Engaging site-based activities such as Music Bingo, Puppy Supply Donation Program, and seasonal events.

• Employee Resource Groups promoting Diversity and Inclusion.

• Green initiatives and community engagement programs including highway clean-up.

• Defined career path with annual performance reviews and growth opportunities.

• WellHub program promoting physical and mental wellness, including onsite fitness center.

• Exclusive discounts through Perkspot from over 900 merchants.

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.

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.

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