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Quality Control Associate, Compliance Specialist

2 months ago

Cleveland, Ohio, United States Abeona Full time
Job Summary

Abeona is seeking a highly motivated Quality Assurance Specialist to support the electronic management of entries in the Enterprise Quality Management System (EQMS), ensuring Good Manufacturing Practices (GMP) compliance.

Key Responsibilities
  • Work on QC compliance tasks of diverse scope, requiring basic knowledge of GMP guidelines, quality systems, corrective actions and preventative actions, and principles of analytical QC testing and laboratory investigations, and principles of equipment calibration and preventative maintenance.
  • Manage Change Controls regarding material changes, laboratory changes, and procedural (SOP) changes.
  • Collaborate closely with colleagues in Quality Assurance department to ensure timely opening and closing of quality records.
  • Adhere to Good Documentation Practices (GDP); review completed executed test forms from peers.
  • Review and revise Abeona documents to improve compliance and efficiency: SOPs, logbooks, analytical methods, test records, and material specifications.
Requirements
  • BS in life sciences, engineering or other relevant discipline with 1 to 4 years of relevant experience.
  • Experience and knowledge in the pharmaceutical and/or biotech industry within a GMP and/or GLP environments preferred.
  • Preferred: Experience with a digital Enterprise Quality Management System (EQMS).
  • Preferred: Experience conducting compliance investigations.
  • Good mathematical and organizational skills.
  • Ability to interact constructively with co-workers to solve problems and complete tasks.