Batch Record Reviewer

August Bioservices • Nashville, TN

5d • Onsite

About The Position

Headquartered in Nashville, TN – one of the fastest-growing and most exciting cities in the United States – August Bioservices is a privately-owned, high-growth, and high-impact Contract Development Manufacturing Organization (CDMO). As a US-based outsourcing partner that provides a wide array of expert drug discovery, drug formulation, and drug manufacturing services to pharma and biotech companies of all sizes, we play a vital role in the global pharmaceutical industry. Our work is instrumental in helping to develop molecules today that can become the life-changing therapies of tomorrow. To support our growth plans, August is investing significant capital in a two-phase expansion project – including building a new state-of-the-art facility adjacent to our current facility. For those seeking dynamic opportunities, rewarding career paths and a chance to make a difference in global health, come grow with August!

The 2nd Shift QA Specialist is responsible for supporting Quality Assurance at August Bioservices. The QA Associate review batch records and coordinates activities in MasterControl at the Nashville TN site.

Requirements

• Bachelor of Science in Biology or Quality, or equivalent skills or experience.
• Two to Three years of experience in a regulated setting.
• GMP compliance knowledge including knowledge of 21CFR210, 211, 820 and the PICS Guide to Good Manufacturing Practices Part 1 and 2 or the EU Guidelines to Good Manufacturing Practice Medicinal Products for Human and Veterinary Use, including Annex 1 and FDA Guidance on Aseptic Processing and Part 11 compliance knowledge preferred.
• Work occurs in a fast-paced environment. Individual must be able to efficiently prioritize own work.

Responsibilities

• Review of batch records to assist the Supervisor of QA with batch release activities.
• Create and/or revise SOPs, batch records, and various GMP documents in support of site operations. Proofread, merge and format documents upon request.
• Initiate document reviews in MasterControl.
• Support Quality on the Floor
• Perform the connection of training to documents in MasterControl.
• Review training documents turned in.
• Issue logbooks and lab notebooks as needed.
• Archive documents turned in from various departments, prepare shipments for long term off site storage.
• Adhere to company policies and applicable regulatory agencies requirements (ICH, FDA etc.) to ensure compliance.
• Support during client audits and regulatory inspections.
• Communicate clearly with cross-functional teams.

What This Job Offers

• Job Type: Full-time
• Career Level: Entry Level
• Number of Employees: 101-250 employees