What are the responsibilities and job description for the QC Analyst II/III Materials position at Organogenesis?
What You Will Achieve:
The QC Analyst II/III performs quality activities in support of quality disposition of materials: material inspection, material testing coordination, data collation, data review, material shipments, document updates etc.. The position interacts with other internal departments, including Production Departments (Apligraf FortaFlex, Dermagraft, Trancyte, Human Tissue Manufacturing, Cell Culture, Cell Banking etc.), Quality Assurance, Materials Management, and Logistics. The position also has interactions with external entities including contractors, test labs and suppliers. The QC Analyst II/III 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 II/III will support QC Material compliance including but not limited to: Change Notifications, non-conforming raw materials, internal/external deviations, OOTr/OOS results etc. The QC Analyst II/III 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.
This position directly supports all activities with QC Materials in direct support of Class II and Class III medical devices that will be manufactured in a new CGMP facility located in Rhode Island. This position will initially be based out of the Canton, MA facility requiring 20% - 50% travel between the Massachusetts Campus and the new facility in Smithfield, RI. Eventual home office at the RI facility with continued 20-30% travel to support Canton material activities as needed.
How You Will Achieve It:
- Perform material inspections.
- Perform tissue 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.
- Author and Revise SOPs.
- Generate trend reports as they relate to Quality Control testing, release metrics.
- Responsible for interdepartmental interactions to ensure customer service needs are satisfied and priorities understood.
- Perform material related Quality System activities: Deviations; Non-conforming material reports; Internal Audit responses, risk assessments, change controls etc.
- Support material qualifications in compliance with company policies and applicable regulatory guidelines.
- Support continuous improvement projects
