Quality Assurance Auditor - Manufacturing

Catalent Pharma Solutions • Greenville, NC

6d • Onsite

About The Position

Catalent’s Greenville, North Carolina site is an oral solid dose development and manufacturing campus that provides services from formulation development through commercial manufacturing and packaging. This Quality Assurance Auditor – Manufacturing position performs established routine and non-routine Quality Assurance tasks with minimal supervision, supporting internal non-commercial clients, external clients, and commercial processes and projects as assigned. The position is 100% onsite in Greenville, NC, with a Monday–Friday, 8:00 a.m.–5:00 p.m. schedule.

The role supports data integrity, compliance, continuous improvement, and a strong quality and safety culture throughout the facility. It provides quality support to manufacturing and packaging operations, including in-process checks, raw material and component release, and batch record review. Work must be performed and documented in accordance with approved procedures and cGMP requirements.

Catalent describes a positive, fast-paced environment focused on continual improvement and innovation, with career development opportunities and a range of employee benefits and site activities.

Requirements

• Bachelor’s degree and three years of pharmaceutical industry experience, including at least one year in a direct Quality Assurance role; or an associate degree and four years of pharmaceutical industry experience, including at least two years in a direct Quality Assurance role; or at least one year of batch record review and on-the-floor Quality Assurance manufacturing support.

Responsibilities

• Ensure integrity of data through accurate transactions, documentation, and tracking of all cGMP activities.
• Advocate for continued improvement of quality standards and development and maintenance of a quality culture across the organization.
• Promote open communication, participation, and information-sharing within and between Quality Assurance teams and throughout the facility.
• Support a climate of quality and safety by identifying and monitoring quality and safety standards.
• Ensure compliance with applicable compendial, internal, and client-specific requirements, including SOPs, Quality Agreements, and applicable compendial chapters.
• Perform in-process Quality Assurance checks.
• Assure raw materials and components are released before manufacturing or packaging.
• Provide real-time support for manufacturing and packaging operations.
• Review batch records.
• Perform and document work in accordance with approved standard operating procedures and cGMPs.
• Perform other duties as assigned.

Benefits

• Competitive paid time off and 8 paid holidays.
• Medical, dental, and vision benefits effective on the first day of employment.
• Tuition reimbursement.
• Site-based activities and seasonal events.
• Employee Resource Groups promoting diversity and inclusion.
• Green initiatives and community engagement programs.
• Defined career path, annual performance reviews, and growth opportunities.
• WellHub physical and mental wellness program, including an onsite fitness center.
• Employee discounts through Perkspot from over 900 merchants.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Education Level: Associate degree