QA MBR Review/Product Disposition Specialist II/III

Norwood, MA

Job ID: 580

Job Req code: 580

Category: Quality Systems

Job Type: OI East

The QA Specialist performs quality activities in support of Amnion product disposition.  The position has a great deal of interaction with many internal departments, including Production, Facilities, Validation, Calibration, Materials, Quality Control, and Logistics.  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 requirements by conducting audits, training programs, data analysis, and documentation reviews.

KEY RESPONSIBILITIES

  • Responsible for the review of Amnion production batch records and applicable forms needed for the disposition of Amnion products.
  • Ensures that all in-process and final product dispositioning activities are conducted in accordance with quality requirements.
  • Ensures that all documentation practices are performed to meet production needs and are in accordance with quality requirements.
  • Responsible for interdepartmental interactions to ensure Operations, Donor Services, Customer Service and Logistics needs are satisfied, and priorities understood.
  • Participates in coordinating daily activities within the assigned functional area.  
  • Support special project team activities, as needed.

Requirements

Requires a Bachelors degree in a scientific discipline or equivalent experience. 3-5 years of related experience in the Biotechnology/Pharma industry and demonstrated knowledge of scientific principles in a GMP/GLP regulated environment.