Sr. Quality Assurance and Regulatory Affairs Specialist

Company: CyberCoders
Location: Lakewood
Posted on: November 22, 2021

Job Description:

If you are a Sr. Quality Assurance and Regulatory Affairs Specialist with experience, please read on!

Top Reasons to Work with Us

• Competitive pay and excellent benefits
• Supportive management and team
• Amazing opportunities for growth
• Gain diversified experience
  What You Will Be Doing
  
  • Support the development, establishment, and management of a comprehensive QMS under GCP, GLP and GMP requirements
  • Ensures the ongoing compliance with lab regulatory agencies (FDA, CAP/CLIA, and other regulatory agencies)
  • Knowledge of global requirements for medical device and IVDs.
  • Monitors and analyzes trends in Laboratory performance to test performance, turnaround time, customer service and other established lab KPI system and process audits, improving process flow and effectiveness
  • Developing and reviewing Laboratory policies and procedures,
  • Maintains a safe environment for Laboratory staff and comply with governmental and institutional regulatory policies.
  • Provides oversight for inspection activities. Serves as liaison for activities involving regulatory (i.e., government) bodies and internal management safety committees, root cause analyses.
  • Lead or coordinate external audits of clinical investigator sites, vendors and service providers
  • Report and address nonconformities, performing causal analysis and CAPAs.
  • Foster an environment of continuous improvement, addressing systemic gaps in our GCP QMS.
  • Lead and/or assist with the preparation, hosting, and closure of GXP regulatory agency inspections.
  • Develop, manage and monitor GCP and GLP documentation
    What You Need for this Position
    
    • Quality Assurance
    • Regulatory Affairs
    • Laboratory Quality Assurance
    • In-Vitro Diagnostics is a plus
    • Medical Device or Pharmaceutical experience
      So, if you are a Sr. Quality Assurance and Regulatory Affairs Specialist with experience, please apply today!
      
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        Anna Thomas - Principal Recruiter - CyberCoders
        
        Applicants must be authorized to work in the U.S.
        
        CyberCoders, Inc is proud to be an Equal Opportunity Employer
        
        All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability, protected veteran status, or any other characteristic protected by law.
        
        Your Right to Work - In compliance with federal law, all persons hired will be required to verify identity and eligibility to work in the United States and to complete the required employment eligibility verification document form upon hire.
        
        CyberCoders will consider for Employment in the City of Los Angeles qualified Applicants with Criminal Histories in a manner consistent with the requirements of the Los Angeles Fair Chance Initiative for Hiring (Ban the Box) Ordinance.

Keywords: CyberCoders, Los Angeles , Sr. Quality Assurance and Regulatory Affairs Specialist, Other , Lakewood, California