Job Description

Overview

Join a high performing team of QA staff to help manage and oversee the Quality Assurance functions focused on GLP audits and compliance of Preclinical and Bioanalytical groups, internal GLP/GCP testing, and overall GXP Quality System support. Conduct internal and external audits, manage QA GLP operation, review data and documentation and provide supervision to QA Specialists.

Responsibilities

  • Manage QA GLP operations
  • Conduct Bioanalytical data transfer audits
  • Oversee execution of quality systems to support GLP testing,
  • Administer, review, follow-up and approve QS documentation
  • Write, review and approve SOPs
  • Trend and report QA GLP quality system related information
  • Perform data review and approval of method and equipment validation
  • Assist in external audits (Vendors, Suppliers, Sub-Contractors Testing Facilities, Clinical)
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