QA Specialist II

Canton, MA

Job ID: 609

Job Req code: 609

Category: Quality Systems

Job Type: Quality Systems

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

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.