Director Aseptic Compliance, Training Material & Batch Release

Glenmark Pharmaceuticals
Monroe, NC
Job Description
Role Overview

The Director of Aseptic Compliance and Training is responsible for leading the development of training and certification/qualification programs, delivery of training sessions, and maintenance of ongoing metrics associated with aseptic manufacturing practices at the site. The position is also responsible for ensuring that activities are appropriately tracked in the Learning Management System (LMS).

What You Will Do

Develop and deliver GMP training modules related to proper aseptic behavior and maintaining an aseptic environment. Lead efforts to drive continuous process improvement activities with the dual goals of reducing risks of contamination, reducing waste, increasing process efficiency, and reducing safety hazards.

Why It Might Be a Fit

The ideal candidate will have the ability to communicate complex requirements to trainees with a broad educational background and experience in microbiological principles. The candidate will also have a working knowledge of cGMPs and emerging regulatory and compliance concerns as related to sterile manufacturing.

Requirements

  • Bachelor's degree in a relevant field
  • 10+ years of experience in aseptic manufacturing and quality operations
  • Strong knowledge of cGMPs and regulatory requirements
  • Experience with training and development programs
  • Leadership and management experience

Benefits

  • Competitive salary
  • Benefits package
  • Opportunities for professional growth and development
  • Collaborative and dynamic work environment
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