Codexis

Manufacturing Quality Associate

49 - Fermentation R&D - Redwood City, CA - Full Time

Manufacturing Quality Associate

At Codexis, we are creating sustainable chemicals, renewable ingredients that make industry more efficient, productive and profitable.  Industrial biotechnology from Codexis reengineers enzymes – nature’s catalysts – and puts them to work to solve real global challenges for the world’s largest companies.  We provide our customers with optimized, faster, flexible, cost-advantaged biosolutions and products tailored for their needs.

Codexis seeks a highly motivated Manufacturing Quality Associate to join the Internal Manufacturing team. This position will report to the Pilot Plant Manager.

Responsibilities:

  • Maintain raw materials inventory, release and dispose raw materials according to the current company procedures.
  • Assist in the management of the raw material vendor qualification process.
  • Write new and revise current SOPs and batch records.
  • Manage the document retention system.
  • Manage the equipment calibration and preventative maintenance program. Schedule calibration services and work with Pilot Plant operations to ensure the timely completion of the service. Maintain up-to-date calibration records.
  • Review equipment logbooks. Maintain freezer temperature records.
  • Assist Pilot Plant management with executed batch production record review. Review executed material production records.
  • Assist Pilot Plant management to provide timely response to deviations, customer complaints, CAPAs, change control requests, SOP reviews and audit responses.
  • Execute basic laboratory procedures such as buffer and media preparations.

Requirements:

  • BS degree in Biology, Biotechnology, Biochemistry, Chemistry, Chemical Engineering or related discipline with a minimum of 2 years of experience in a pharmaceutical quality controlled environment (cGMP, ISO 9001).
  • Hands-on experience in pharmaceutical manufacturing operations is desirable.
  • Excellent technical writing skills.
  • Organized, capable of detailed planning and able to write and strictly follow procedures.
  • Detail oriented.
  • Able to work effectively within a team environment and cross functionally across the organization.
  • Able to occasionally work outside of regular business hours and perform basic hands-on manufacturing procedures.

The position comes with a competitive compensation and benefits package.  For more information about our plans for the future, and to be considered for this career opportunity, please visit www.codexis.com.

EOE
PRINCIPALS ONLY
NO AGENCIES OR THIRD PARTIES

 

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