Quality Assurance Associate.
This position is a key member of the Aziyo Biologics team and as such is involved in executing the Company’s short- term goals and objectives as it relates to quality assurance.
This position will perform donor and production record review efforts for all musculoskeletal products. This position will ensure all records are in compliance with appropriate systems, policies and procedures and perform final disposition of tissue products. This position will partner with operations to ensure compliance with applicable regulations and accomplish company goals of restoring health and mobility to the greatest number of patients possible.
Position reports to the Director, Quality & Regulatory Affairs
Essential Duties & Responsibilities
- Perform Quality Control inspection of final product allografts.
- Manage transfer and release of final products.
- Perform record review of all production-related records to ensure compliance with applicable standard operating procedures, Current Good Tissue Practice (cGTP) and AATB Standards.
- Maintain Quality records per standard operating procedures.
- Investigation of any non-conforming events (NCE), CAPA investigations and complaint investigation and report generation.
- High School Diploma or equivalent. A Bachelor’s degree in a life science discipline preferred.
Experience and Skills
- Minimum 1 year experience in the Quality field.
- Experience in a FDA-regulated environment, with knowledge of 21 CFR Part 1271, Human Cells, Tissues, and Cellular and Tissue-Based Products (HTC/P) preferred.
- Ability to read and interpret complex medical documents, procedures, standards, regulations, etc.
- Ability to prioritize projects and adapt to shifting priorities.
- Strong knowledge of standard PC-based Microsoft Office applications.
- Excellent written and verbal communication skills.
- Some operations require bending, standing long hours, pushing and/or pulling objects to a machine or/on a cart.
- Ability to distinguish colors.