Pharmaceutical Quality Assurance

Burlington, MA

Great opportunity! Temp to Perm or Perm – Great Team and Opportunity! In this quality assurance role, the appropriate candidate will be responsible for the implementation, functioning, and monitoring of quality assurance activities. This includes monitoring biological and chemical studies, and creating reports in conformance with GLP practices. Candidates will review GMP, GLP and non-GLP reports for accuracy with reference to protocols, Quality Assurance Standards, Standard Operational Procedures, laboratory precision and accuracy limits, as well as reviewing all protocols for compliance and accuracy. Other quality assurance responsibilities include maintaining equipment performance, calibration records and preventative maintenance logs. Included duties are performing system and phase audits according to GLP and ISO guidelines, as well as all other activities required from quality assurance. Qualifications • A bachelor’s degree in a life science is required, preferably in Biology. • At least 1 year experience in an FDA regulated environment, with basic knowledge of study design and review practices. • GLP and GMP knowledge preferred. • Must have strong documentation and coordination practices, be detail oriented and enjoy high work volume via computer.

Contact mhood@reardonassociates.com for more details.

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Posted on May 08, 2015