Quality Assurance Auditor

Catalent Pharma Solutions • Greenville, NC

14d • Onsite

About The Position

Quality Assurance Auditor The Quality Assurance Auditor will provide key quality support and leadership to development, operations, and laboratory personnel for commercial and pre-commercial processes and projects. Position Summary This position is 100% on-site at the Greenville site. The Quality Assurance Auditor will lead in promotion of a culture of proactive quality and compliance across the organization, facilitating continuous improvement. Catalent’s Greenville, N.C. facility specializes in end-to-end turn-key solutions for oral solid dosage forms, including integrated formulation development, analytical services, commercial manufacturing, and packaging. This state-of-the-art facility has had over $100M of investments in recent years and features fit-for-scale capacity with potent handling capabilities, ideal for orphan or targeted drug development. The Role 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.

Requirements

• Bachelor’s degree with three years of professional experience required in the pharmaceutical industry, preferably with one year in a Quality role or;
• Associate degree with four years of professional experience required in the pharmaceutical industry, preferably with two years in a Quality role or;
• 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.

Responsibilities

• 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.

Benefits

• 152 hours of PTO + 8 paid holidays
• Catalent offers rewarding opportunities to further your career!
• Join the global drug development and delivery leader and help us bring over 7,000 life-saving and life-enhancing products to patients around the world.
• Catalent is an exciting and growing international company where employees work directly with pharma, biopharma and consumer health companies of all sizes to advance new medicines from early development to clinical trials and to the market.

What This Job Offers

• Job Type: Full-time
• Career Level: Entry Level