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.
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.
We provide a Total Rewards package designed to make life better – both at work and at home.
- Annual Bonus Opportunities for All Employees
- 15 Days Starting PTO (Annual Increase) + Sick Time Off + Volunteer Time Off
- Paid Parential Leave
- Annual Company Shutdown in December
- Comprehensive Medical, Dental + Vision
- 401K Company Match + Immediate Vesting
- Backup Daycare and Eldercare
- Monthly Employee Appreciation Events and Food Truck Fridays
- Employee Discount Programs
- Tuition Reimbursement
- Casual Dress Code
- Wellness Programs
- Community Outreach Opportunities
If you meet the requirements above, and would like to apply for this position, please visit our website at www.ajibio-pharma.com and click on the “Careers” section. Please be sure to note where you saw our ad posting.
New hires will pass a background check and drug screen as a condition of employment.
We are an EOE dedicated to a diverse work force and Drug Free work environment. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.