Quality Assurance Specialist

6 days ago


Cambridge, Massachusetts, United States The Steely Group Full time
Job Overview

This role is an exciting opportunity for a seasoned Quality Assurance Specialist to join our client's team as a Compliance and Quality Systems Expert. Located in Cambridge, MA, this hybrid position offers the ideal blend of remote work and onsite collaboration.

Key Responsibilities
  • Support the development and implementation of quality systems and compliance strategies that align with regulatory requirements.
  • Collaborate with cross-functional teams to ensure effective product complaint handling, including intake, reconciliation, and reporting.
  • Provide training and guidance on product complaint handling processes and procedures.
  • Assist in the revision and maintenance of quality documents, including SOPs and WI.
  • Contribute to regulatory inspection preparation and support audits as needed.
Requirements and Qualifications
  • Bachelor's degree in Life Sciences, Chemistry, or Engineering, or equivalent experience.
  • Minimum 5 years of experience in Pharmaceutical Quality or Regulatory.
  • Prior experience in managing product complaints and adverse event processes.
  • Familiarity with GxP regulations and industry-standard software such as Veeva Quality Docs and eQMS.
Why Choose This Role?

This opportunity offers a competitive salary of $66.67 per hour, a unique blend of remote and onsite work, and the chance to work with a leading firm in the pharmaceutical industry. If you're passionate about quality assurance and compliance, apply today



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