Quality Assurance Auditor

US-MA-Bedford
1 week ago(12/7/2017 8:44 AM)
Job ID
2017-1035
# of Openings
1
Category
Quality

Overview

Performs internal audits, supplier evaluations and supplier audits to evaluate compliance with applicable procedures and regulatory requirements. Responsible for all aspects of auditing including scheduling, performing audits, generating audit reports, and communicating audit findings.

Responsibilities

  • Create schedules for Internal and Supplier audits
  • Generate audit agenda/plans
  • Perform internal audits to verify compliance with applicable internal procedures regulatory requirements
  • Perform vendor/supplier audits including audits of raw material suppliers, contract laboratories, and contract research organizations
  • Prepare audit reports and make recommendations for approval/disapproval of suppliers
  • Communicate audit findings and supplier performance to management
  • Follow-up on corrective and preventive actions
  • Maintain and continuously improve audit procedures and checklists
  • Maintain approved supplier list and supplier files
  • Establishing and maintain Supplier Quality Agreements
  • Participate in preparation and support of regulatory inspections
  • Perform other quality assurance duties as assigned

Qualifications

  • Bachelor’s degree in relevant scientific discipline
  • Five years of experience in pharmaceutical or biotech industry
  • Excellent organizational skills and attention to detail
  • Strong verbal and written communication skills
  • Computer literacy, proficiency in MS Office, Excel, PowerPoint etc.
  • Ability to work with minimal supervision
  • Knowledge of FDA and international regulations and GxP guidelines
  • Ability to travel ~20%
  • Quality auditor certification preferred

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