Senior Quality Assurance Specialist

1 month ago


Reston, Virginia, United States EPM Scientific Full time
Job Summary

We are seeking a highly skilled Senior Quality Control Analyst to join our team at EPM Scientific. The successful candidate will be responsible for managing and supporting external testing activities within the Quality Control group to ensure alignment with our quality program.

Key Responsibilities
  • Organize and schedule external testing to support product release and stability testing under cGMP guidelines
  • Manage external data review according to the production schedule and stability program
  • Act as the primary point of contact with contract laboratory facilities
  • Evaluate and monitor the performance of contract labs
  • Coordinate investigations at contract laboratories to ensure thorough technical content and compliant documentation
  • Collaborate with internal Subject Matter Experts (SMEs) and Quality Assurance teams
  • Coordinate the issuance and approval of Quality Agreements with contract labs
  • Draft Master Service Agreements, as needed
  • Participate in GMP audits of contract labs
  • Coordinate and lead quarterly meetings between contract labs and QC management
  • Identify and resolve technical issues at contract laboratories in collaboration with QC management
  • Lead and oversee daily quality control metrics meetings
  • Manage compliance items and metrics within the group
Requirements
  • Current or prior experience working in a regulated environment
  • Demonstrated ability to work independently or as part of a team
  • Strong troubleshooting and problem-solving skills
Education and Experience

A BS/BA in Chemistry, Biology, or a related field with 5+ years of experience in laboratory management and analytical testing, as well as previous supervisory or leadership experience. Relevant experience may be considered in lieu of educational requirements.



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