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Quality Associate

  • Job type: Permanent
  • Location: Marlborough
  • Salary: Competitive
  • Job reference: BD0919172
  • Sector: EPM Scientific, Quality
  • Date posted: 19/09/2017
Quality Associate needed for rapidly expanding Top-Tier CRO in Malborough, MA

A rapidly expanding top-tier pharmaceutical CRO is looking to hire Quality Associate to support the department in the daily upkeep the quality system. The ideal candidate will have an auditing background and be well versed in all GCP activities. 

The company strives for organic growth so career advancement for this individual is uncapped.

The Quality Associate will have the following responsibilities:
  • Provide quality oversight in support of clinical trials
  • Support development and administration of client Quality Systems
  • Document maintenance, internal audits, vendor qualifications, CAPAs, and training
  • Schedule and perform internal/vendor audits
  • CAPA log maintenance and coordination
The ideal candidate will have the following skill set:
  • 2-5 years quality assurance experience with pharmaceutical/med device or CRO
  • B.A./B.S. or equivalent experience; CQA experience necessary
  • Qualified auditor (internal/external); BIMO auditing experience a plus
  • Knowledge of GCP, GDP, FDA guidelines, ISO standards
  • Excellent organizational, project management, interpersonal, and communication skills
  • Willingness to travel as project dictates
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