QC Chemistry Associate III - 2nd Shift

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 QC Chemistry Associate III who will be responsible for conducting routine analysis of in process, release and stability assays for proteins, peptides and small molecules under general supervision. The role 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.

Responsibilities:

· Conducts and reviews routine analysis and testing of samples under general supervision and may focus analysis and testing in a particular QC arena.

· 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.

· Generation and collaborator Standard Operating Procedures (SOPs) for internal use and client specific methods.

· Maintains lab area including routine cleaning of benches, biosafety cabinets, shelving and floors.

· Collects and disposes of lab wastes according to established procedures.

· 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

· Trains lower level personnel on quality control methods and SOP’s.

· Participate in Client Interface meetings as may be required or necessary.

· Scheduling for in-process, stability and release testing if necessary

· Technical writing of investigations for deviations and Out of Specifications (OOSs)

· 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 Ajinomoto Bio-Pharma’s cultural values and aligns daily actions with department goals and company culture.

Requirements :

· High School Diploma or equivalent experience required. Bachelor’s degree strongly preferred in a Life Sciences discipline or equivalent.

· 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.

We provide a Total Rewards package designed to make life better – both at work and at home.

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.

#LI-KC1 The anticipated hourly range for candidates who will work in California is $23.75 - $33.25

The final salary offered to a successful candidate will be dependent on several factors that may include but are not limited to the type and length of experience within the job, type and length of experience within the job, type and length of experience within the industry, education, etc. Ajinomoto Bio-Pharma Services is a multi-state employer and this salary range may not reflect positions that work in other states.