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 provide oversight to ensure adherence with the quality systems within the Richmond site. These systems include: discrepancy investigation, shop floor auditing, discrepancy investigation, CAPAs, batch record review and others as appropriate. 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.
Essential Duties & Responsibilities
• Perform direct observations and record reviews for quality related documentation 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) identified during record review, CAPA investigations and complaint investigations.
• Support the Document Control process as needed.
A Bachelor’s degree in a life science discipline preferred.
Experience and Skills
· Minimum 2 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.
· Experience in aseptic operating environments.
· 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