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.

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

• 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

• 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

• 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.
• Well Hub 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…