Quality Assurance Specialist (v227)

  • Contract Duration: 6-8 months to start, Hybrid Onsite
  • Clinical
  • Boston, MA

Website Lenox Executive Search


Lenox Executive Search is looking to fill a current opening for a Quality Assurance Specialist, with one of our global pharmaceutical clients. This is a contract position that has the potential to become permanent based on performance.

Key Duties and Responsibilities of a Quality Assurance Specialist:

  • Performs analytical data review for commercial release and stability and verify documentation and determines acceptability by using standard operating procedures.
  • Perform quality review/ approve of raw data and COAs in support of commercial batch release when needed.
  • Upload the vendor created protocols in electronic document management system and update all commercial stability-controlled documents including Vendors Stability Protocols, Initiation Forms, and Data Tables. In addition, update JMP files for all commercial products if needed.
  • Provide support to Clinical analytical data review as needed
  • Support the day-to-day management of the analytical data from external CMO – Update trackers in a timely manner upon receipt of data from external vendors and follow up for any major delays or issues.
  • Communicates proactively with internal and external partners and management.
  • Assists department management with monthly/quarterly Quality System data review metrics and reporting
  • Escalate critical and major finding to Quality management related to GXP Operational areas.

Knowledge and Skills of a Quality Assurance Specialist:

  • Strong communication and influencing skills
  • Ability to evaluate quality matters and make decisions utilizing risk-based approach
  • Proficiency in using Microsoft Office applications
  • Some experience with quality metrics, dashboards, analysis, and improvement programs
  • Some experience with network-based applications such as Oracle, Veeva, etc
  • Basic knowledge of current industry trends and regulatory requirements

Education and Experience of a Quality Assurance Specialist:

  • Bachelor’s degree in relevant field is required
  • Typically requires 2 years of experience or the equivalent combination of education and experience
Upload your resume here.

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