Quality Assurance Auditor - Manufacturing

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.

Responsibilities

• Ensure integrity of data through accurate transactions, documentation, and tracking of all cGMP activities.
• Advocate for continuous 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).
• Perform in‑process QA checks.
• Assure release of raw materials and components prior to manufacturing/packaging.
• Provide real‑time support activities for manufacturing and packaging operations.
• Review batch records.
• Perform all work in accordance with approved standard operating procedures and cGMPs.
• Other duties as assigned.

Minimum Requirements

• Bachelor’s degree with 3 years of professional experience in the pharmaceutical industry, including 1 year in a direct QA role; or Associate degree with 4 years of professional experience, including 2 years in a direct QA role.
• At least 1 year of batch record review and on‑the‑floor quality‑assurance manufacturing support.
• Ability to handle and manipulate objects using hands and arms.

Benefits

• 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.
• 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 an onsite fitness center.
• Exclusive discounts through Perkspot from over 900 merchants.

Schedule

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