We are currently seeking a QA Batch Release Associate III who is responsible for assuring compliance with Quality Assurance (QA) requirements, applicable regulatory requirements, including assisting with audits, training programs, and documentation review. The Associate III collaborates with internal team members to ensure compliance to specifications, processes, and procedures.
Reviews and approves executed and non-executed lot file documentation in support of the manufacture and testing of Drug Substance and Drug Product.
Independently investigates, troubleshoots, and rectifies issues as a result of QA analysis.
Performs reviews of production batch records and associated data for product release, and determines if records are within range of cGMP regulations.
Provides QA oversight and performs real time, on-the-floor documentation review during manufacturing operations.
Represents QA on assigned clients and attends client meetings.
Regular and reliable attendance on a full time basis [or in accordance with posted schedule].
Responsible for exhibiting professional behavior with both internal and external business associates that reflects positively on the company and is consistent with the company’s policies and practices.
Embodies Aji Bio-Pharma’s cultural values and aligns daily actions with department goals and company culture.
Bachelor’s degree in a Life Sciences discipline or equivalent experience required.
Minimum of three (3) years of relevant experience in batch release documentation review, QA or equivalent.
Working knowledge of cGMP regulations 21CFR Part 11, 210, 211, 600 & EU guidelines and good documentation practices.
Knowledge of Fill Finish and Biologics production environments strongly preferred.
About Ajinomoto Bio-Pharma Services
Together, Let’s Make A Difference.
At Ajinomoto Bio-Pharma Services, our mission is to help improve the health of humankind. As a leading, global contract development and manufacturing organization, with sites in the US, Belgium, Japan and India, we work together to empower our clients to bring drugs to market.
Every team member, from manufacturing and quality programs to development and facilities services are a critical component to this effort. At our US location, our focused expertise and capabilities makes us one of the industry’s top leaders for large molecule manufacturing and aseptic drug product fill in vials and syringes.
We believe our people are our greatest asset and we are committed to providing our employees with an environment that supports personal and professional growth. We take pride in knowing our efforts are helping countless patients for years to come.
Do you enjoy working in a dynamic, inspiring team with an amazing culture? If you do, then Ajinomoto Bio-Pharma Services is the place for you.