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Senior Consultant, GMP Quality Assurance

Cambridge, Massachusetts

Post Date: 08/15/2017 Job ID: 1612 Job Category: Clinical: Quality

Senior Consultant, GMP Quality Assurance

My client is a growing oncology pharmaceutical company looking to add a strategic consultant to their team.

The Quality Assurance consultant will be available for ad hoc/1 day a week (remote) quality support and compliance oversight for controlled documentation including SOP’ s, batch records, material specifications, product specifications and study protocols and reports.   The incumbent will assist the VP of Technical Operations in questions on leading quality and compliance activities of early to late stage clinical trials.

8-10 hours per week, remote possible, 1-2x per month onsite as needed

  • Assists and supports the organization with initial compliance and ongoing preparation, testing and monitoring of conformance to established quality assurance processes and standards for manufacturing and production.
  • Assist with the creation, review and modification of Standard Operating Procedures (SOPs)
  • Performs evaluation of internal controls, communications, risk assessments and maintenance of documentation as related to compliance with internal and external safety, quality, and regulatory standards.
  • Assists with GMP and GCP audits and risk assessments.

  • BS in life sciences/health related discipline. Chemistry degree preferred/plus
  • Minimum 5 years of experience in biotech/pharmaceutical industry; 3 or more years of experience in quality assurance
  • Experience with working with and qualifying external vendors
  • Working knowledge in both GMP & GCP








Aaron Goldman
Clinical Recruiter

Aaron is a spirited guy who likes to make things happen. He has been a Clinical Recruiter for the past five years, and says his greatest reward comes when a candidate accepts an offer and he hears the excitement in their voice - You know you have helped someone change their life!
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