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QC Chemistry Associate III

Employer
Ajinomoto Bio Pharma Services
Location
San Diego, CA
Start date
Sep 21, 2020

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.

 

Ajinomoto Bio-Pharma Services is currently seeking a QC Chemistry Associate III. This position is 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 perform routine and non-routine analysis with methods such as pH, Density, Viscosity, Conductivity, Appearance, Moisture Content, Particle Analysis, SDS-PAGE, ELISA, Agarose Gel Electrophoresis (AGE), CE-SDS, and Extractable Volume.

 

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, shelving, cabinets, 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:

  • Bachelor’s degree in a Life Sciences discipline or equivalent required.
  • Minimum of three (3) 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.

  • Annual Bonus Opportunities for All Employees
  • 15 Days Starting PTO (Annual Increase) + Sick Time Off + Volunteer Time Off
  • 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

 

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.

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