Job ID: #8601

QA Manager

Boston, MA
Science Science
QA / QC

 

Responsibilities of the QA Manager:

  • Develop, implement and manage QA systems, conduct periodic reviews of QMS, and implement corrective actions.
  • Evaluate audit responses and follow up on responses and audit closure.
  • Conduct external vendor audits for clinical sample analyses to ensure compliance with GMP, GXP, and CLIA/CAP, as applicable.
  • Write QA SOPS and provide regulatory input for other department SOPs.
  • Evaluates responses to inspection reports and performs follow-up with respondents, management, or others, if needed, to ensure resolution.

Requirements of the QA Manager:

  • Bachelors degree in scientific/life-sciences or related field
  • Must have 5+ years management experience in Quality Assurance in a Pharmaceutical or biotechnology environment.
  • Experience with CLIA/CAP regulations and Clinical laboratory audits is preferred.
  • Extensive knowledge of GxP Regulations with a minimum of 5 years working in a GLP, GCP or GMP environment.

 

Commonwealth Sciences is a professional recruiting firm specializing in Science, Engineering and Green Technologies. We unite industry professionals with exciting career opportunities by leveraging our technical expertise, advanced recruiting tools and years of staffing experience. CWS works with a variety of disciplines and levels from Research Associates to Scientists, Engineers, Managers and Directors. Our clients value the basic integrity, customer service and industry expertise that defines our organization.

Commonwealth Sciences, Inc.

 

 

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    Commonwealth Sciences is a professional recruiting firm specializing in Life Science, Medical Device, and Engineering Technologies. We unite industry professionals with exciting career opportunities by leveraging our technical expertise, advanced recruiting tools and years of staffing experience. CWS works with a variety of disciplines and levels from Research Associates to Scientists, Engineers, Managers and Directors. Our clients value the basic integrity, customer service and industry expertise that defines our organization.