Quality Assurance Auditor - Analytical Review

About the role

Catalent’s Greenville, North Carolina site is a major oral solid‑dose development and manufacturing campus that delivers end‑to‑end, turnkey solutions from formulation development through commercial manufacturing and packaging. The site supports both commercial products and potent or targeted therapies, including orphan drugs, and features fit‑for‑scale infrastructure, potent‑handling capabilities, and a strong regulatory track record.

We have an opportunity for a Quality Assurance Auditor – Analytical Review. This position performs 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.

Responsibilities

• Ensure integrity of data through accurate transactions, documentation, and tracking of all cGMP activities.
• Advocate for continual improvement of quality standards and foster a quality culture across the organization.
• Create an environment of open communication, participation, and information‑sharing within Quality Assurance and throughout the facility.
• Support the development of a climate of quality and safety by identifying and monitoring quality and safety standards.
• Ensure compliance with all compendial, internal, and client‑specific requirements (e.g., SOPs, Quality Agreements, General and Informational Chapters in multiple compendia).
• Review and approve laboratory reports and Certificates of Analysis (COAs).
• Review and approve stability reports (LWRs) in SLIM.
• Release raw materials in the ERP system.
• Perform work in accordance with approved standard operating procedures and cGMPs.
• Provide real‑time support for laboratories.
• Other duties as assigned.

Requirements

• Bachelor’s degree in a Life Sciences discipline with at least 3 years of pharmaceutical industry experience and at least 1 year in a direct QA role.
• Associate degree in a Life Sciences discipline with at least 2 years of pharmaceutical industry experience 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.
• Ability to handle and manipulate objects using hands and arms.

Benefits

• Positive, fast‑paced environment focused 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 finish or earn a new degree.
• 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 an onsite fitness center.
• Exclusive discounts through Perkspot from over 900 merchants.

Schedule

Shift: Monday‑Friday, 8:00 am – 5:00 pm. Location: Greenville, NC. 100 % onsite.