Job Information
Abeona Associate, QC- Quality Records in Cleveland, Ohio
Position Overview
The Quality Control Associate, Quality Records supports the electronic management of entries in the Enterprise Quality Management System (EQMS), to support Good Manufacturing Practices (GMP) compliance. This individual serves as an embedded quality assurance representative within the Quality Control department. The quality control department at Abeona controls the commercial manufacture of viral vector and cell therapy products at Abeona’s facility in Cleveland, OH. This position is full-time, on-site in Cleveland, OH.
Essential Duties and Responsibilities
Works 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.
Work within Abeona’s Enterprise Quality Management System (EQMS): author deviations, laboratory investigations, and corrective action / preventative action (CAPA) plans. Document results of Effectiveness Checks for changes.
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); r eview 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.
Performs other duties as assigned by management.
Qualifications
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
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