Sr. Quality Control Associate

Location
92121, San Diego
Posted
Apr 23, 2018
Discipline
Quality, Science/R&D
Required Education
Bachelors Degree
Position Type
Full time

Let’s Make Things Happen!

 

Ajinomoto Althea, Inc. is a fully integrated contract development and manufacturing organization providing clinical drug process development and manufacturing services to global biotechnology and pharmaceutical companies.

 

Althea is a leading expert in aseptic filling of drug product in vials and syringes, and our focused expertise and capabilities make us one of the industry’s top leaders for cGMP microbial fermentation of recombinant proteins and plasmid DNA. In conjunction with these manufacturing operations, Althea offers comprehensive development services including: upstream and downstream process development, complex formulations, lyophilization cycle, analytical development, product release and ICH-compliant stability testing.

 

Now is an exciting time to join Althea. We have talented people working together to help our clients advance their innovative product pipelines. We believe that people are our greatest asset and we are committed to providing our employees with an environment that fosters personal and professional growth.

 

Our work atmosphere is fast paced, stimulating and customer focused. Employees take pride in knowing our efforts are helping countless patients for years to come.

 

Althea is currently seeking a Sr. Quality Control Associate to provide QC laboratory routine testing in support of process development, in-process and stability sample testing of highly potent products (HPP). This support will be largely focused on biochemical analysis (ELISAs, cell-based potency assays), gels, spectroscopy, and compendial methods. QC Associate I will be required to operate and maintain instrumentation in the HPP laboratories for which they are trained.

 

 

Responsibilities:

  • Performs routine QC testing according to Standard Operating Procedures with GDP documentation.  Analyzes data and processes data using a variety of scientific software.
  • Prepares, solutions and buffers according to standard operating procedures to support QC operations.
  • Responsible for maintenance of laboratory chemical inventory of QC testing materials and supplies.  Maintains lab area including cleaning of benches, biosafety cabinets and shelving according to 5S standards.
  • Maintains instrumentation according to standard operating procedures.
  • Initiates revisions to current SOPs/Protocols/Reports and authors new SOPs/Protocols/Reports with appropriate level of independence.
  • Ensures analytical methods have been properly validated/qualified as appropriate in compliance with GMP prior to using the method.
  • Recognized at the department level as a subject matter expert in ELISA and Cell Based Potency Assays [CBPA].  Performs, reviews and troubleshoots assays.  May set up CBPA capability in house in the future.
  • Participates in regulatory inspections.
  • Embodies Althea’s cultural values and aligns daily actions with department goals and company culture.
  • 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.

 

Requirements:

  • Typically requires a BS with a minimum of 6 years, or a MS with a minimum of 3 years or related experience.
  • Minimum of 3 years’ experience performing ELISAs.  Experience performing CBPA and compendial methods preferred.
  • Experience with GMP and FDA regulations required.
  • Ability to perform testing in a highly accurate and reproducible manner.
  • Effective problem solving/troubleshooting skills.
  • Detail oriented with strong written and verbal communication skills.

 

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

 

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.