Senior Quality Control (QC) Associate

Senior Quality Control (QC) Associate

A large pharmaceutical company in the South San Francisco, CA area is looking for a Senior Quality Control Associate to join their team. This is an excellent opportunity to join an exciting company with a stable pipeline.

Senior QC Associate Responsibilities:

* Lead and support projects to qualify computerized lab equipment/systems in Quality Control GMP laboratories (does not include enterprise-wide systems e.g., LIMS or Empower).
* Author qualification documents including requirement specs. protocols and reports.
* Train others in the group on the fundamentals of computer system validations.
* Perform minor troubleshooting of computer-related issues (major or complicated issues are escalated to IT).
* Support system owners in maintaining their equipment in a qualified, GMP state.
* Work with equipment manufacturers/vendors to assess and acquire new technologies.
* Improve existing qualification processes and practices.

Senior QC Associate Required Skills:

* Working knowledge of GMPs including US and EU requirements.
* Deep understanding of validation fundamentals specifically computer system validations CSV). Should be familiar with Part 11 and Annex 11 requirements and ISPE/GAMP 5.
* Administration of Windows-based computers (e.g., account creation and security settings).
* Advanced computer system administration skills preffered including the ability to write simple .bat scripts and to manage users and computers via Active Directory.
* Excellent communication and writing skills.
* Able to lift up to 25 lbs.

Senior QC Associate Education Requirements:

Bachelor's Degree and 5+ years of experience validating GMP equipment (at least 3 years of CSV experience).

An equivalent combination of education and/or experience is acceptable

If you are interested in applying to this role, please resond to this job positing with an updated version of your resume ASAP.

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