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Quality Assurance Specialist, Quality Records

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.
  • 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.