About Us

We are a leading regenerative medicine company in the advanced and acute wound care space and are always looking for exceptional talent. Join a company where you will have an opportunity to grow professionally and personally and give strength to others by Empowering Healing. Our advanced wound care products are specially developed for the successful treatment of chronic and acute wounds. Our comprehensive portfolio of skin substitutes and other regenerative medicine products empower our patients with life-changing solutions. Our strength is giving others strength.

Learn more about Careers at Organogenesis

What You Will Achieve:

The QC Analyst III/IV performs quality activities in support of material inspection, material testing coordination, data collation, data review, material disposition and final product inspection. The position interacts with other internal departments, including Apligraf Production, FortaFlex Production, Human Tissue Manufacturing, Cell Culture, Cell Bank Production, Quality Assurance, Materials, and Logistics. The position also has interactions with external entities including contractors, test labs and suppliers. The QC Analyst III/IV performs a wide variety of activities to ensure compliance with applicable regulatory requirements in support of inspecting, coordinating testing, trending, and reporting results. The QC Analyst III/IV will lead internal QC Material specific assessments including but not limited to: Change Notifications, non-conforming raw materials, internal/external deviations, OOTr/OOS results etc. The QC Analyst III/IV will support continuous improvement initiatives and participate in Quality System requirements for new and existing materials, e.g. risk management, CAPA and change controls. Periodic weekend, holiday and evening on-call coverage may be required.

How You Will Achieve It:

• Author and Revise SOPs.
• Lead material related Quality System activities: Deviations; Non-conforming material reports; Internal Audit responses, risk assessments, change controls etc.
• Coordinate and assess change notifications in collaboration with QA Compliance and other internal departments
• Support material qualifications in compliance with company policies and applicable regulatory guidelines.
• Support continuous improvement projects
• Responsible for interdepartmental interactions to ensure customer service needs are satisfied and priorities understood.
• Perform material inspections.
• Perform tissue inspections.
• Perform Final Product Inspections.
• Submit test requests to the QC functional areas to coordinate testing.
• Coordinate shipping of materials to external test labs.
• Collate results and document results to submit to Quality Assurance for final dispositioning.
• Generate trend reports as they relate to Quality Control testing.