Quality Control Associate - Chemistry

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 at Ajinomoto Bio-Pharma Services, 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 andaseptic drug product fill in vials and syringes.

We believe our people are the greatest asset and we are committed to providing our employees with an environment that fosters personal and professional growth. We take pride in knowing our efforts are helping countless patients for years to come. If you enjoy working in a fast-paced, inspiring, and values-driven culture, Ajinomoto Bio-Pharma Services is the place for you.

Together, Let’s Make A Difference.

Ajinomoto Bio-Pharma Services is currently seeking a Quality Control Associate - Chemistry responsible for conducting routine analysis of in process, release and stability assays for proteins, peptides and small molecules under general supervision. The QC Associate may focus in a specialized area and provide routine analysis and testing according to standard operating procedures in any of the following areas:  Sample testing and release, development of assays, and performing qualifications. The ideal candidate will have ELISA experience in a cGMP environment.

Responsibilities:

• Performs releases testing assays for in process, final product, raw materials, stability and other routine samples.
• Adheres to cGMP requirements and SOP’s.
• Compiles data for documentation of test procedures.
• Responsible for standardization and preventative maintenance of laboratory equipment.
• Reviews data obtained for compliance specifications and reports abnormalities.
• Reviews batch records and product specifications as required.
• Generates Standard Operating Procedures (SOPs) for internal use and client specific methods.
• Executes the transfer, qualification and validation of new testing methods with guidance from supervisor, which may include writing protocols and reports.
• Manages IQ/OQ/PQ of new instruments with guidance from supervisor.
• May participate in Client Interface meetings.
• Technical writing of investigations for deviations and Out of Specifications (OOSs).
• Maintains lab area including routine cleaning of benches, biosafety cabinets, shelving and floors.
• Collects and disposes of lab wastes according to established procedures.

Requirements:

• High School Diploma or equivalent required. Bachelor’s degree in a Life Sciences discipline or equivalent strongly preferred.
• Minimum of four (4) years of relevant experience in a laboratory setting.
• Experience with GMP, aseptic techniques, troubleshooting, and data entry.
• Ability to perform testing in a highly accurate and reproducible manner.
• Proficiency with Microsoft Office applications.
• Detail oriented with strong written and verbal communication skills.
• Ability to work independently, within prescribed guidelines, or as a team member.
• Demonstrated ability to follow detailed directions in a laboratory environment.

If you meet the requirements above, and would like to apply for this position, please visit our website at www.ajibio-pharma.cmo.com and click on the "Careers" section.  Please be sure to note where you saw our ad posting.

Successful candidate must 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.

Qualified M/F/D/V candidates are encouraged to apply.