Quality Control Associate - Separation Sciences

Location
92121, San Diego
Posted
Jan 09, 2019
Required Education
Bachelors Degree
Position Type
Full time

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 QC Associate, Separation Sciences responsible for conducting routine and non-routine HPLC analysis. May focus in a specialized area and provide routine analysis and testing according to standard operating procedures in any of the following areas: in-process and finished formulations, in-process and purified biological products (proteins, peptides, antibodies).

Responsibilities:

  • Conducts routine and non-routine HPLC analysis according to standard operating procedures to support in-process, release, and stability testing in a manner consistent with cGMP requirements.
  • Compiles data for documentation of test procedures in a manner consistent with GDP requirements.
  • Analyzes data and results and presents conclusions to supervisor in tabular, graphical, and written format.
  • Reviews data obtained for compliance to specifications and reports abnormalities to supervisor.
  • Assists in the transfer, qualification, and validation of new testing methods with guidance from supervisor, which may include writing protocols and reports.
  • Assists in investigations related to deviations and out of specification results.
  • Initiates revisions to current SOPs and authors new SOPs based on methodology being transferred into the QC laboratory.
  • Responsible for standardization and maintenance of laboratory equipment and maintains lab area.
  • 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.

 

Requirements:

  • Bachelor’s degree in a Life Sciences discipline or equivalent required.
  • Minimum of 2-4 (two to four) years of relevant experience in a GMP setting preferred.
  • Minimum of 3 (three) years of relevant HPLC experience in a laboratory setting.
  • Experience with GMP, FDA regulations, ICH guidelines for analytical method validation, analytical method troubleshooting, and data analysis desired.
  • 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 athttp://www.ajibio-pharma.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.