Quality Assurance Specialist

Company: GForce Life Sciences
Location: Oceanside
Posted on: August 2, 2022

Job Description:

QA Specialist III
SummaryOur Client is seeking a highly motivated individual to join us as a QA Specialist III, Quality Assurance, Compliance. In this role you will be responsible for a variety of Quality activities to ensure compliance with applicable quality objectives and regulatory requirements. This individual will be located at our Oceanside, CA site and report to Director of Quality Assurance. This is a Contract To Hire role.
Duties / Expectations of Role

• Leading or supporting compliance, data integrity, policies and practices to ensure compliance with regulatory requirements and the Client's procedures and Corporate Policies.
• Conducting Gap Analysis for various systems.
• Leading Internal Audits, preparing audit reports and reviewing/ evaluation audit responses. Supporting responses to Corporate Audits.
• Be able to review quality control, validation and other records for regulatory compliance and site procedures.
• Reviewing and approving Quality Control data, protocols/ reports, test methods, specifications and other documentation related to QC department.
• Reviewing test results (in-house and by Contract Laboratory) for product release and Stability Study; ensuring that QC deviations / discrepancies, change controls and other applicable records are resolved/closed prior to batch release.
• Supporting, reviewing and approving (as applicable) records / activities related to Quality Control, such as Laboratory Investigations, Out-of-Specifications, deviations, non-conformities.
• Proposing corrective/ preventive actions for discrepancies related to QC. Capability to implement such improvements with minimum supervision.
• Supporting test methods validations conducted by QC.
• Reviewing test results and annual reports for Environmental Monitoring (EM) program.
• 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
  • 5+ years of experience with BS degree in the biological sciences or related field.
  • Working knowledge of electronic 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, Power Point and other applications. Familiarity with electronic systems for Batch Record, Quality Management Systems, Agile (Oracle EBS), SAP, Veeva and Smartsheet is a plus.

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