QA Specialist II; MBR & Donor File Review

Norwood, MA

Job ID: 579

Job Req code: 579

Category: Quality Systems

Job Type: Quality Systems

The QA Specialist performs quality activities in support of donor file reviews, Amnion production record reviews, and Amnion product releases.  The position has a great deal of interaction with many internal departments including, Operations; Donor Services, Amnion Production, Facilities, Validation, Calibration, Materials, Quality Control, Customer Service and Logistics.  The position may also have interactions with external entities including contractors, suppliers, Inspectors and customers.  The QA Specialist performs a wide variety of activities to ensure compliance with applicable regulatory requirements by conducting batch record review, audits, data analysis, and other documentation reviews.
 
  • KEY RESPONSIBILITIES
  • Responsible for the review of Donor files, donor site audit forms, Amnion production batch records and applicable forms needed for the release of Amnion products.
  • Responsible for ensuring that all blood tests are within the defined acceptance criteria and that all enrollment criteria were met.
  • Ensures that in-process Tissue 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

Minimum requirements include: Associates/Bachelors degree with 2-5 years experience in GMP/GLP environment and a knowledge of scientific principles in a regulated industry.