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Shop Floor QA Specialist II

Snap Staffing

Shop Floor QA Specialist II

Brea, CA
Full Time
Paid
  • Responsibilities

    Shop Floor QA Specialist II (Orange County, CA)

    SNAPSHOT!

    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 admin@snapstaffing.com