QA Specialist II; MBR & Donor File Review

Norwood, MA

Job Req code: 579

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 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 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.

JOB 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.
• Ensure that in-process Tissue dispositioning activities are conducted in accordance with quality requirements.
• Ensure 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.
• Participate in coordinating daily activities within the assigned functional area. 
• Support special project team activities, as needed.

Requirements

• Associates/Bachelors degree
• 2-5 years experience in GMP/GLP environment
• Knowledge of scientific principles in a regulated industry