Quality Systems and Compliance Specialist

1 month ago


Cambridge, Massachusetts, United States Stratacuity: Proven Scientific Placement Full time
Job Overview

We are seeking a highly skilled Quality Systems and Compliance Contractor to join our team at Stratacuity: Proven Scientific Placement. This role involves supporting Quality Systems and Compliance by managing product complaint handling, acting as document control backup, and assisting with regulatory inspection preparation.

Key Responsibilities
  • Manage product complaint intake and coordination with partners for timely resolution and safety compliance.
  • Develop training and assist in revising handling procedures and reporting to maintain compliance standards.
  • Act as backup for document control and support regulatory inspection preparation and execution.
Requirements
  • Bachelor's degree in life sciences, chemistry, or engineering with 5+ years of experience in Pharma Quality/Regulatory.
  • Proven expertise in managing product complaint processes and adverse event reporting.
  • Knowledge of GxP regulatory compliance, including privacy and documentation.
  • Experience with Veeva QualityDocs and eQMS is a plus.
About Stratacuity

At Stratacuity, we value ethics and building lasting relationships with exceptional biopharmaceutical talent. We take great care to protect your personal information and will only share it with your direct consent. Our team is committed to providing a safe and inclusive work environment.

We are an Equal Employment Opportunity/Affirmative Action Employer and welcome applications from diverse candidates. If you require an accommodation during the application process, please contact us.



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