Quality Assurance Specialist
Lab Support - Boston, MA

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We are looking for two contract resources to assist us with our current GCP and GLP QA workload (in-house QA activities and external auditing). Responsiblities include collaborating with Clinical Research / Clinical Operations personnel to ensure that clinical trials comply with SOPs, FDA regulations, and ICH/GCP guidelines. Provides expert GCP compliance and general QA support; acts as liaison between product development teams and QA. Plans, coordinates and conducts internal and external (both domestic and international) GCP-related audits.
  • BS in a scientific discipline or equivalent.
  • A minimum of 3-5 years experience in a Clinical Quality Assurance / Compliance role
  • Working knowledge of Code of Federal Regulations and ICH Guidelines governing clinical research and familiarity with current initiatives.

  • Knowledge of GLP regulations / auditing techniques preferred.

  • Experience in developing and writing SOPs.

  • Must be able to partner with a diverse group of staff/consultants with different strengths and skills and have the ability to prioritize work, manage multiple projects, while maintaining quality.

  • Ability to work independently and as part of a team, detail oriented.

  • Experience in international compliance / auditing a preferred.

On Assignment - 23 months ago - save job
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