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Specialist, QA Operations

3 months ago

Omaha, United States TALENT Software Services Full time

Are you an experienced Specialist, QA Operations with a desire to excel? If so, then Talent Software Services may have the job for you Our client is seeking an experienced Specialist, QA Operations to work at their company in Novato, CA.


Position Summary: This position reports to the Quality Assurance Supervisor/ Manager/ Senior Manager and is responsible for quality oversight of one or more processes relating to making, assessing, and releasing for products produced in Novato manufacturing facilities.


Primary Responsibilities/Accountabilities:

  • Provide quality oversight of one or more portions of operations including, but not limited to;
  • Direct observation of manufacturing operation for adherence to GMP.
  • Review of GMP documentation from manufacturing and/ or QC, which can include log books, batch records and test records.
  • Issuance of Production Batch Record to Manufacturing
  • Scanning and archiving executed production batch records
  • Ensure manufacturing and QC adherence to company policies/procedures, regulatory licenses, industry standards, and GMP regulations. Working knowledge of United States and European regulatory requirements, guidelines, and recommendations a plus (additional jurisdictions a plus).
  • Revise QA-related procedures as needed.


Qualifications:

  • Attention to detail. MS Office. Ability to operate basic office equipment, e.g. scanners, and printers.
  • Associate degree or higher.