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Quality Control Associate

2 months ago

Cleveland, Ohio, United States Abeona Full time

Position Overview
The Quality Control Associate for Quality Records plays a vital role in the electronic oversight of entries within the Enterprise Quality Management System (EQMS), ensuring adherence to Good Manufacturing Practices (GMP).

This position acts as an integrated quality assurance representative within the Quality Control division, which is responsible for the commercial production of viral vector and cell therapy products.

Key Responsibilities
1. Engage in QC compliance activities of varied scope, necessitating foundational knowledge of GMP regulations, quality management systems, corrective and preventive actions, as well as principles of analytical QC testing and laboratory investigations.
2. Operate within the Enterprise Quality Management System (EQMS): author deviations, conduct laboratory investigations, and develop corrective action/preventive action (CAPA) plans.
3. Document outcomes of Effectiveness Checks for modifications.
4. Manage Change Controls concerning material, laboratory, and procedural adjustments.
5. Collaborate closely with Quality Assurance colleagues to ensure prompt initiation and conclusion of quality records.
6. Uphold Good Documentation Practices (GDP); review completed test forms from peers.
7. Review and enhance Abeona documents to boost compliance and efficiency, including SOPs, logbooks, analytical methods, test records, and material specifications.
8. Perform additional duties as assigned by management.

Qualifications
A Bachelor’s degree in life sciences, engineering, or a related field, coupled with 1 to 4 years of pertinent experience.
Experience and familiarity with the pharmaceutical and/or biotech sectors within GMP and/or GLP settings is preferred.

Preferred Skills
- Experience with a digital Enterprise Quality Management System (EQMS).
- Background in conducting compliance investigations.
- Strong mathematical and organizational abilities.
- Capacity to engage constructively with colleagues to resolve issues and accomplish tasks.