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QA Manager

Company: Gator Bio
Location: Palo Alto
Posted on: February 25, 2021

Job Description:

Gator Bio, the leading developer and manufacturer of Next Generation Bio-Layer Interferometry (BLI) biosensor technology and services utilized by life science researchers within the biopharma, drug discovery, pharmaceuticals and biotherapeutics. Headquartered in Palo Alto, CA, we provide BLI label-free solutions involving instrumentation and consumables utilized for measuring real-time biomolecular interactions. General applications include quantitation, kinetic analysis, and epitope binning.
Gator Bio is looking for an experienced Quality Assurance Manager to lead the GMP compliance of QC, Manufacturing and Product Development. ResponsibilitiesCreate, implement, and manage a GMP Equipment Control Program, including:

  • Identify all in-house GMP equipment and enter in Excel spreadsheet tracking system;
  • Installation and Operational Qualification status and compliance by arranging for contract qualification where necessary;
  • Calibration status and compliance by arranging for contract calibration where necessary;
  • Equipment control monitoring systems;
  • Equipment file documentation;Create, implement, and manage a GMP Material Control Program, including:
    • Identify GMP materials requiring control;
    • Part numbering;
    • Specification development;
    • Incoming receipt, inspection, control, and release processes;
    • Lot status change process and status labeling;
    • Inventory tracking and material dispensing;
    • Shipping controls;
    • Material file documentation;Create, implement, and manage a Supplier Management Program, Including:
      • Identify all GMP and other supplier types requiring control and oversight
      • Qualify all suppliers
      • Initiate and drive supplier surveillanceEnforcement of GMP understanding and compliance related to equipment, material control and supplier management & some SOP preparationQualifications
        • BS or MS in biology, chemistry, biochemistry, or other related science.
        • At least 5 years' experience working in a GMP QA operations environment with experience in GMP equipment programs, GMP material control programs and supplier management systems a must.
        • Must have in depth knowledge of FDA GMP regulation related to Quality operations.
        • High level of integrity, flexibility, and teamwork.
        • High attention to detail; excellent organizational skills; ability to work on multiple projects.
        • Ability for problem-solving and decision-making.
        • Excellent interpersonal and verbal communications skills.
        • Proficient in Microsoft Office Suite - Word, Excel, PowerPoint, etc.

Keywords: Gator Bio, Palo Alto , QA Manager, Executive , Palo Alto, California

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