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Shop Floor QA Specialist II

Snap Staffing - Brea, CA

Shop Floor QA Specialist II (Orange County, CA)


Are you looking for an exciting career opportunity with a technology-based special pharmaceutical company focused on the development and commercialization of therapeutic injectable drugs? THEN READ ON! Our client has a full array of expertise, including advanced scientific research in the area of drug delivery systems, process development, patent analysis, and regulatory compliance!

Immediate need for a Shop Floor QA Specialist II in Orange County, CA who possess:

  • Bachelor’s degree in chemistry or biology; or equivalent combination of education and experience.
  • 3 - 5 years of related manufacturing and quality assurance in the pharmaceutical industry
  • Broad knowledge of scientific theories, instrumentation, and techniques
  • Thorough knowledge of GMPs, GLPs and pharmaceutical products
  • Working knowledge of all phases of Pharmaceutical manufacturing and laboratory operations
  • 1 year writing, editing, or reviewing documents such as SOPs, work instructions, batch records, guidelines, etc. Technical Writing experience a plus

Key responsibilities include:

  • QA oversight during manufacturing activities such as filling, compounding, component preparation, capping, inspection, labeling, and packaging operations
  • Review executed batch record
  • Make quality decisions on the floor during commercial manufacturing
  • Review batch record documentation and logbooks concurrent with manufacturing operations
  • Verify line clearance activities for manufacturing and packaging area
  • Monitor the inspection and packaging lines and perform AQL inspections
  • Monitor the production schedule and ensure adequate line coverage support from QA
  • Perform routine quality inspection of filling, compounding, component preparation, capping, inspection, labeling, packaging, and warehouse
  • Train new employees on QA Shop Floor Associate’s functions
  • Support QADC team to issue controlled documents as needed
  • Facilitate manufacturing deviations and investigations
  • Other quality assurance duties as assigned and required to meet relevant 21 CFR Part 210 and 211

For immediate considerations please email your resume to

Posted On: Wednesday, April 27, 2022

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