Agenus

Computer Systems Validation Engineer

US-CA-Berkeley
Job ID
2017-1234
Category
Quality

Overview

Conduct external vendor evaluation audits to determine qualifications.  Maintain the vendor qualification program, which may include multiple sites.  Conducts internal quality audits and risk assessments. Prepares audit plans and understands the specific issues to be evaluated. Executes audits to ensure compliance with recognized standards (i.e., GCP, GLP, GMP), regulatory authorities and in-house and external specifications and standards. Reports discrepancies. Develops formal written reports to communicate audit results to management and regulatory compliance agencies, if applicable, and makes recommendations as appropriate. May facilitate work of external auditors during on-site visits. Individual must have strong working knowledge of cGMPs and applicable regulatory guidance. Must possess excellent written and verbal communication skills and the ability to work independently.

Responsibilities

    • Conduct internal and external audits
    • Generate audit reports
    • Conduct follow up review to assure corrective action has been implemented
    • Travel to vendor audits as needed (25% travel time anticipated)
    • Participate in various department initiatives and projects as needed and appropriate
    • Ensure compliance to internal and external specifications and GxP standards
    • Manage vendor qualification program in compliance with current industry standards
    • Up to 25% travel

Qualifications

  • BS or Equivalent
  • 5-7 years direct auditing experience, preferably in the field of biotechnology and immune-oncology
  • Ability to assess multiple vendor types, including raw material suppliers, contract laboratories, manufacturers and distributors for GxP compliance. 
  • Preference for auditor able to support GCP, GLP and GMP functions

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