Quality Assurance Auditor

Quality Assurance Auditor

Provide quality support and leadership to development, operations, and laboratory personnel for commercial and pre-commercial processes and projects.

This position is 100% on-site at the Greenville site.

• 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).
• Provide real‑time support activities for manufacturing and packaging operations.
• Review batch records.
• Ensure all work is performed and documented in accordance with approved standard operating procedures, in compliance with cGMPs.
• All other duties as assigned.

• Bachelor’s degree with three years of professional experience required in the pharmaceutical industry, preferably with one year in a Quality role.
• Associate degree with four years of professional experience required in the pharmaceutical industry, preferably with two years in a Quality role.
• At least one year of batch record review and on the floor quality assurance manufacturing support required.
• Position requires the capacity to handle and manipulate objects using hands and arms.

• Spearhead exciting and innovative projects.
• Fast‑paced, dynamic environment.
• High visibility to members at all levels of the organization.
• 152 hours of PTO + 8 paid holidays.

Catalent is an Equal Opportunity Employer, including disability and veterans.

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