QA Monitor III

Canton, MA

Job ID: 600

Job Req code: 600

Category: Quality Systems

Job Type: Quality Systems

Job Summary

The QA Monitor will have responsibility for performing QA monitoring of the cleanrooms. This position will monitor cleanroom behaviors of the operators and facility issues and communicate with appropriate departments for a quick resolution. Additional responsibilities include walk-through audits of GMP areas, supporting closure of exceptions (Deviations, CAPA, Out of Service etc.), document review, Validation review, release of Facility/Equipment systems and facility liaison.  The Individual will have interaction with many internal departments, including, Apligraf Production, Cell Culture, Facilities, Validation, Calibration, Materials, Quality Control, and Logistics. The position may also have interactions with external entities including contractors, suppliers, and customers. The QA Monitor performs a wide variety of activities to ensure compliance with applicable regulatory requirements by conducting inspections, batch record review, document reviews, and Validation review.

Key Responsibilities

  • Performs monitoring of cleanrooms, QC lab areas to ensure that all internal procedures are followed and are compliant with CGMP regulations and guidelines.
  • Performs Process Audits as needed.
  • Assist in the review of production batch records, data forms, Validation reports and other associated documentation. Helps identify discrepancies and works to obtain resolution of the discrepancies with the responsible individual(s).
  • Release of Facility/Equipment Systems
  • Support investigations to aid in closure of exceptions

 

Preferred Education and Experience

  • Requires an Associate’s degree or equivalent with a minimum of 2-5 years of related experience in a GMP/GLP regulated environment.
  • Clean room experience is required. Previous batch record review experience is preferable.