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 laboratory concepts, laboratory investigations, corrective actions and preventative actions, and change controls.
Support Raw Material and Manufactured Media quality control practices to comply with FDA Good Manufacturing Practices (GMPs), and United States Pharmacopeia (USP).
Completes laboratory work with precision, and maintains hardcopy paperwork and electronic data in organized manner, in compliance with company Good Documentation Practices (GDP).
Provides input to improving QC systems and procedures to improve GDP compliance.
Reviews and revises analytical methods, SOPs, test records, and critical reagent specifications.
Proactively communicates laboratory issues to manager. Supports laboratory investigations related to test failures, discrepancies and deviations.
Work within Abeona’s Quality System: support compliance regarding deviations, laboratory investigations, and corrective action / preventative action (CAPA) plans.
Adhere to Good Documentation Practices (GDP) and Good Manufacturing Practices.
Helps maintain laboratory in GMP compliant state, including participating in cleaning, instrument routine and preventative maintenance, logbook use, etc.
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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