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Quality Assurance Specialist II, Compliance

Company: GForce Life Sciences
Location: Oceanside
Posted on: August 7, 2022

Job Description:

Quality Assurance Specialist II - Compliance
SummaryOur Client is seeking a highly motivated person for the role of QA Specialist II- Compliance. This individual will be responsible for a variety of Quality activities to ensure compliance with applicable quality objectives and regulatory requirements and will be located at our Oceanside, CA site and report to Senior Manager of Quality Assurance. This is a Contract To Hire role.
Duties / Expectations of Role

  • Supporting compliance, data integrity, policies, and practices to ensure compliance with regulatory requirements and the Client's procedures and Corporate Policies.
  • Conducting or supporting activities for Gap Analysis for various systems.
  • Conducting or supporting Internal Audits and Corporate Audits, preparing audit reports, and reviewing/evaluating audit responses.
  • Be able to review quality control, validation, and other records for regulatory compliance and site procedures.
  • Reviewing test results (in-house and by Contract Laboratory) for product release and Stability Study.
  • Supporting, reviewing, and approving (as applicable) records/activities related to Quality Control, such as Laboratory Investigations, Out-of-Specifications, deviations, and non-conformities.
  • Reviewing test results and annual reports for Environmental Monitoring (EM) and other trending reports, generated by QC.
  • Provide information for Product Quality Reviews and participate in review/approval of PQRs.
  • When requested, write, revise and review SOPs, manufacturing documents, methods, specifications, protocols, and reports
  • Supporting Management during regulatory agency inspections, the Client's Global, and other audits.
    Mandatory Requirements
    • 3+ years of experience with a BS degree in the biological sciences or related field.
    • Working knowledge of electronic Quality Management Systems is a plus.
    • Working knowledge and ability to apply GMPs in conformance to U.S. and EU standards.
    • Ability to effectively negotiate and build collaboration amongst individuals.
    • Proficient in MS Word, Excel, PowerPoint, and other applications.
    • Familiarity with electronic systems for Batch Record, Quality Management Systems, Agile (Oracle EBS), Veeva, and Smartsheet is a plus.

Keywords: GForce Life Sciences, Oceanside , Quality Assurance Specialist II, Compliance, Other , Oceanside, California

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