Specialized Recruiting. Temporary Staffing. Managed Services. 800 876 2314


Quality Assurance Manager

Employment Type Permanent
Field of Work Clinical/Medical

 

Primary Responsibilities

  • Ensures GxP work is done in compliance with applicable laws, regulations and guidelines
  • Works closely with internal and external QA and CMC colleagues through all phases of drug development
  • Executes all Quality system elements, which include but are not limited to investigation of product complaints, deviations, OOS investigations, document creation and control, site audits, change control, validation (e.g. process, cleaning, analytical method, etc.), stability, batch record review, and product disposition
  • Participates in the review, evaluation and approval of contract manufacturing, testing, research and/or laboratory facilities
  • Reviews and approves GxP related documents as requested and appropriate
  • Supports QMS management and maintenance for GxP activities
  • Participates on project teams and sub-teams as needed and assigned
  • Ensures documents and records are kept in compliance with regulations and SOPs

Required Qualifications and Background

  • BA/BS in science or engineering
  • A minimum of 5-7 years of experience working in a Biotech or Pharmaceutical FDA regulated industry in QA or in a related field, or an equivalent combination of education, training and/or experience from which comparable knowledge, skills and abilities have been attained
  • 3rd party Vendor Audit
  • Small molecule
  • CMC
  • Batch Record Review and SOPs
  • Experience working with solid oral and liquid dosage forms
  • Ability to multitask and work in a fast-paced environment
  • Ability to work in a matrixed environment
  • Working knowledge of cGMPs (CFR/ICH) and applicable international regulations/guidelines
  • Experience working with outside vendors and contractors
  • Strong understanding of GxP requirements for Phase I through commercial stage
  • Ability to work in a virtual manufacturing environment
  • Ability to travel for both domestic and internationally - 10% - 15% Travel – Domestic/International
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