Quality Control Analyst I/II

Canton, MA

Job Req code: 986

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 QC Analyst I/II performs quality activities in support of material inspection, material testing coordination, data collation, data review, material disposition and final product inspection. The position has interaction with other internal departments, including Apligraf Production, FortaFlex Production, Human Tissue Manufacturing, Cell Culture, Cell Bank Production, Quality Assurance, Materials, and Logistics. The position also has interactions with external entities including contractors, test labs and suppliers. The QC Analyst I/II performs a wide variety of activities to ensure compliance with applicable regulatory requirements by inspecting, coordinating testing, trending, and reporting results.   Periodic weekend, holiday and evening on-call coverage may be required.

KEY RESPONSIBILITIES

  • Perform material inspections.
  • Perform Final Product Inspections.
  • Submit test requests to the QC functional areas to coordinate testing.
  • Collate results and document results to submit to Quality Assurance for final dispositioning.
  • Perform visual inspection of finished product.
  • Generate trend reports as they relate to Quality Control testing. 
  • Revise SOPs.
  • Responsible for interdepartmental interactions to ensure customer service needs are satisfied and priorities understood

 

Requirements

  • Bachelor’s Degree in Science or equivalent.
  • 1-5 years of related experience in a GMP regulated environment.
  • Materials and/or final product inspection experience required.
  • Pass Annual Vision Screening Test
  • Able to lift 50 lbs. and 50% of time standing in workday.

A pre-employment physical and lift test is required for this position.