QA Disposition Specialist II
Job Req code: 712
Category: Quality Systems
We have unique opportunities 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. Empowering Healing.
Organogenesis corporate headquarters is located in Canton, Massachusetts, and we have an additional site in Norwood, Massachusetts. Our Canton location is the manufacturing site for PuraPly® AM (which heals acute and chronic wounds), and Apligraf® (for the treatment of surgical wounds). Our Norwood location manufactures ReNu® (offering regenerative and anti-inflammatory properties to create an environment that reduces pain) and NuCel® (which provides an enhanced environment for tissue growth, repair and healing). Canton is also the location for Customer Service, Reimbursement and other corporate teams, supporting our full range of products.
The QA Disposition Specialist II performs quality activities in support disposition of multiple product releases. The position has a great deal of interaction with many internal departments, including Apligraf Production, FortaFlex Production, Cell Culture, Facilities, Validation, Calibration, Materials, Quality Control, and Materials Management. The position may also have interactions with external entities including contractors, suppliers, and customers. The QA Specialist performs a wide variety of activities to ensure compliance with applicable regulatory.
• Review batch records to support new and existing products.
• Assist in all activities associated with transferring final product for shipment
• Review internal document for accuracy and compliance with GMP’s
• Participate in cross-functional teams to support department and company goals
• Perform additional QA functions as required
• Support special project team activities, as needed.
2-4 years of GMP experience in a Medical Device/Biotechnology industry. A Bachelor’s degree with demonstrated knowledge of scientific principles in a GMP/GLP regulated environment is desirable
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