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Quality Control Analyst

Company: Templaris
Location: Poway
Posted on: August 1, 2022

Job Description:

Quality Control Analyst is responsible for working closely with the Quality Team members and Supervisor to assist in the maintenance and work of the Quality Control group. The Quality Control group functions include ensuring the quality, safety, and control of the products manufactured and processes performed. The facility is a GMP compliant facility that utilizes controlled clean room manufacturing of biological and regenerative medical products and Contract Manufacturing Organization services.Primary Responsibilities:

  • Environmental Monitoring of GMP facility
  • Enforce and support aseptic techniques and environment
  • Perform Quality Control inspections and testing (i.e. Endotoxin, Sterility, Mycoplasma, Cell Culture, Flow)
  • Help implement corrective actions and quality improvements related to Quality Control areas of responsibility
  • Record keeping, organization and archivingSupport Quality with the day-to-day management of the following:
    • Organization of Quality Control test samples to include receipt and storage of quality testing samples
    • Help with day-to-day control of records,
    • Proficient in Microsoft Excel is preferred
    • Assure that result data/files are complete, organized and reviewed in a timely manner
    • Help trend quality test and environmental results
    • Assist in investigations and quality control processesSecondary Responsibilities:
      • Support Quality Staff with regulatory audits (FDA & State inspections), internal and external audits as needed.
      • Support production and manufacturing activities as needed as a quality representative
      • Perform additional job-related duties as required, to include document revisions as neededRequired Skills/Abilities:
        • Team minded individual with flexibility and dedication
        • Demonstrated ability to handle and prioritize multiple projects to meet deadlines
        • Efficient time management and organizational skills
        • Solid verbal communication skills with the ability to clearly apply written communication
        • Understanding of the field of cell therapy processing preferred
        • Analytical skills and solutions-oriented approach to problem-solving
        • Ability to work effectively in a fast-paced, rapidly changing environment with others
        • Demonstrated ability to work independently as well as part of an integrated team
        • Position may require some "off-standard hours"

Keywords: Templaris, Poway , Quality Control Analyst, Professions , Poway, California

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