QA Training Specialist II

Canton, MA

Job Req code: 735

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 QA Specialist performs quality activities in support of GxP operations. The position has a great deal of interaction with many internal departments, including but not limited to: Production, Facilities, Validation, Materials Management, Quality, Regulatory and Sales.  The position may also have interactions with external entities including contractors and suppliers.  The QA Specialist performs a wide variety of activities to ensure compliance with applicable regulatory requirements by conducting audits, training sessions, data analysis, and documentation reviews.

 

KEY RESPONSIBILITIES

 

  • Use the OI Quality Management System (QMS) to maintain training records for all employees.
  • Analyze data from QMS for purposes of trending and troubleshooting
  • Work with Managers and Training Coordinators to maintain/update appropriate curricula for their departments.
  • Support special project team activities, as needed.
  • Develop and/or perform training sessions on various GxP subjects when required, either in-person or virtually (Teams, Skype etc.).

 

QS TECHNOLOGY COMPETENCIES

 

  • Working knowledge of data analysis. Understands and utilizes problem-solving process. Creates and maintains databases.
  • Develop/Update Training Modules for New Hire GMP Training and GMP Refresher Training, in accordance with all procedures.
  • Develop/Update Training Modules and matrices used by other departments, when requested.
  • Perform additional QA functions as required
  • Communicate any areas of deficiency to the responsible individuals
  • Assists in generating and/or revising procedures that comply with regulations and internal policies.
  • Understands corrective and preventive actions concepts and systems. 
  • Advanced knowledge of application tools such as Word and Excel is required. Familiarity with PowerPoint, Teams and Outlook is desirable.

Requirements

Requires a bachelor’s degree in a scientific discipline or equivalent related experience, and a demonstrated knowledge of scientific principles in a GMP/GLP regulated environment.