Quality Assurance Auditor - Analytical Review

About the role

We have an opportunity for a Quality Assurance Auditor – Analytical Review. This position requires the ability perform 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
• 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)
• Review/approve laboratory reports and COAs
• Review/approve stability reports (LWRs) in SLIM
• Release of Raw Materials in ERP System
• Ensure all work is performed and documented in accordance with approved standard operating procedures, in compliance with 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 professional experience in the pharmaceutical industry and at least 1 year in a direct QA role
• Associate degree in a Life Sciences discipline with at least 2 years of professional experience in the pharmaceutical industry 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
• Position requires the capacity to handle and manipulate objects using hands and arms

Benefits

• Positive and fast-paced working environment focusing 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 you finish your degree or earn a new one
• 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 onsite fitness center
• Exclusive discounts through Perkspot from over 900 merchants

Schedule

Monday‑Friday 8:00am‑5:00pm, 100% onsite in Greenville, NC