Quality Assurance Specialist II/III

Quality Assurance Specialist II/III Canton, MA

Job Req code: 972

Category: Quality Systems

Organogenesis corporate headquarters is located in Canton, Massachusetts, including manufacturing, R&D, customer service, reimbursement and other corporate teams supporting our full range of products. 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 by Empowering Healing.

The QA Specialist 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.

 

KEY RESPONSIBILITIES

• 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.

Requirements

PREFERRED EDUCATION AND EXPERIENCE

2-8 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.