Quality Control Associate
San Diego, CA 
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Posted 1 month ago
Job Description

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 Quality Control Associate to join our team! In this role you will conduct routine and non-routine HPLC, cIEF, Mass Spec., and particle size analysis. You 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.
  • Embodies Aji Bio-Pharma’s cultural values and aligns daily actions with department goals and company culture.

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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.
  • Minimum of 3 (three) years of relevant HPLC experience in a laboratory setting.
  • Experience with Mass Spec, cIEF, and particle size testing desired.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.

 

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

 

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.

 

 


"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."


 

Job Summary
Start Date
As soon as possible
Employment Term and Type
Regular, Full Time
Required Education
Bachelor's Degree
Required Experience
2 to 4 years
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