What are the responsibilities and job description for the Quality Assurance Specialist II/III position at Organogenesis?
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 QA Specialist performs quality activities in support of new product production and quality review and disposition in support of clinical and commercial product production. The position has a great deal of interaction with many internal departments, including Production, Facilities, Validation, Calibration, Materials, Quality Control, and Logistics. The position also has interactions with external entities including contractors, suppliers, and customers. The QA Specialist performs a wide variety of activities to ensure compliance with applicable regulatory requirements by performing documentation reviews both internally and externally, batch approval of produced product, exception approvals and validation approvals.
How You Will Achieve It:
- Review batch records and test records and perform final product inspection/release in support of new and existing products.
- Review validation records to support new or improved processes and/or equipment release.
- Coordinate “Customer Service” meetings between QA and other departments.
- Give recommendations for action to be taken to resolve product and/or process issues.
- Participate in cross functional meetings for the production and release of clinical product
- Initiate and lead cross-functional teams to support department and company goals. Generate and distribute meeting minutes.
- Participates in coordinating daily activities within the assigned functional area.
- Support special project team activities, as needed.