Quality Assurance Associate.

Quality Assurance Associate.

Who We Are

We’re a team with a shared purpose to bring innovative solutions to physicians and patients around the globe. What we do or don’t do each day affects the lives of patients and that’s why we are dedicated to the development of our employees who work collectively to achieve our goals.

What Are We Doing in Richmond, CA?

We process human tissue to produce high-quality allografts for transplantation. These allografts are used in medical and surgical procedures to help physicians and their patients address a variety of medical conditions.

Our Team

Our Team operates in accordance with Aziyo’s established standard operating procedures (SOPs). Every member is a key part of the process to ensure each donor’s Gift is honored by ensuring the highest level of performance and seeking continual improvement opportunities to optimize its usage. This is why we are seeking an experienced Quality Engineer with a strong background in Quality Assurance, to join our team.

Quality Assurance Associates

Our QA Assoiates are key members of the Aziyo Biologics team and as such are 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.

What We Value:

• Dedication to Quality – Our Quality team members are critical in ensuring that every Aziyo product that is delivered to our customers exceeds standards and meets regulatory requirements.
• A Sense of Purpose – We value the Gift of tissue donation, and our success is attributed to the like-minded individuals who work with these donations to improve patient outcomes globally and are proud to be part of something bigger than themselves.
• Innovative Solutions – We value the ability to think critically and creatively to identify problems and develop effective solutions. Our team members are ever-evolving, agents of growth who are committed to continuous improvement.

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.

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.

Education

• High School Diploma or equivalent.
• Bachelor’s degree in a life science discipline preferred.

Physical Requirements

• Some operations require bending, standing long hours, pushing and/or pulling objects to a machine or/on a cart.
• Ability to distinguish colors.