Batch Record Reviewer at August Bioservices – Nashville, Tennessee

Batch Record Reviewer

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 Batch Record Reviewer 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. 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.
• 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.

Requirements

• Bachelor of Science in Biology or Quality, or equivalent skills or experience.
• Two to Three years of experience in a regulated setting.
• 2+ years of experience with batch record review.
• 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.

Shift

• Monday - Friday, 9:00am - 6:00pm

At August Bioservices, Our Credo is our culture. Everything we do, we do with great care. We believe in the promise of discovery and the power of science to transform lives. We assert that excellence is not a static destination, but a standard, and an every-day measuring stick of our advancement. We aspire to unlock the potential in every person, every process and every molecule from start to finish. We are committed to doing the right thing the first time and every time, meeting or exceeding all regulatory requirements. We strive to be exceptional, preferred and indispensable partners for our customers; responsible and engaged citizens within our communities; and active, mindful stewards of our environment. We are August Bioservices. We are pointing the way forward. If this sounds like your kind of working environment, we want you on our team!
August Bioservices is an equal opportunity employer and values diversity. All aspects of employment including the decision to hire, promote, discipline, or discharge, will be based on merit, competence, performance, and business needs. August Bioservices does not discriminate on the basis of any status protected under federal, state, or local law.