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Senior Quality Assurance Associate

Company: nxtgen search
Location: Torrance
Posted on: August 6, 2022

Job Description:

Responsible for performing quality assurance activities that support GMP production activities. Ensure compliance to procedures and policies. Interface with personnel from other departments, including management, in order to understand and address any concerns or needs. This position requires flexibility, initiative, ability to work well with others and willingness to take on new responsibilities. The focus of the role is primarily technical document review and approval activities; however additional activities will be assigned based on the Senior Associate's skill level. Responsibilities:

  • Review batch records, executed aseptic process simulation forms, QC test data, and environmental monitoring reports. Review validation data, equipment identification forms, calibration specification sheets, and equipment change forms. Communicate required changes for specific projects and help establish norms and standards.
  • Review SOPs, Protocols, and Reports.
  • Administration of the GMP material part number system and Part Number list.
  • Create or revise new Item Specifications under the supervision of management.
  • Assign lot numbers and issue/reconcile batch production records.
  • Generate and/or approve product labels.
  • Issue and retire laboratory and equipment logs.
  • Maintain the QA Archive.
  • Track and trend data and provide reports to management, as required.
  • Provide support in the preparation for, conduct of, and follow-up activities associated with inspections or regulatory/accrediting agencies.
  • Participate in interdepartmental project teams as required.
  • Support supplier qualification activities, as required.
  • Serve as a backup for the document control function.
  • Support supplier qualification activities, as required.
  • Train R&D personnel on QA controlled documents.
    Skills and Experience
    • Proficiency in Microsoft Word and Excel
    • Knowledge of Access and Visio is preferred
    • Ability to interpret a variety of instructions furnished in written, oral, or diagram form
    • Must be knowledgeable of cGMP regulations, especially 21CFR211.
    • Must have the following personal attributes: personal accountability, work ethic, sound judgment, eagerness to learn and continuously improve, and a dedication to quality. Education
      • B.S. required; science or related field preferred.
      • 2+ years of experience in pharmaceutical, biopharmaceutical, or other regulated industry.

Keywords: nxtgen search, Torrance , Senior Quality Assurance Associate, Other , Torrance, California

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