Valeant Pharmaceuticals

Aseptic Training Specialist

US-FL-Tampa
Job ID
9533
Category
Operations
Pos. Type
Full Time

Overview

Aseptic Training Specialist

 

Hands-on trainer for aseptic behavior inside the filling and compounding aseptic areas while analyzing trends to implement proactive solutions.

Responsibilities

  • Administer aseptic behavior certification program for associates working in the manufacturing aseptic environment and audit associates entering aseptic environment on a daily basis.  Ensure compliance with gowning and aseptic techniques.
  • Monitor Process Simulation Media Fills and commercial runs to identify additional training needs and develop training materials to address those opportunities.            
  • Requires consistent coordination with Manufacturing & QA Management and generation of reports.
  • Develop and deliver GMP course modules related to proper aseptic behavior and maintaining an aseptic environment.
  • Coach and mentor operators on the importance of maintaining low bio burden during line clearing/cleaning, runs, routine and non-routing interventions.
  • Evaluates and develops action plans for employees showing alert limits in the garment sampling.
  • Assess equipment and work environment to ensure it is suitable to enable good aseptic behaviors and makes recommendation to management on changes needed.
  • Writes non-conformance investigations.
  • Evaluates from the aseptic perspective any equipment modification, process changes, new equipment and new tools to be introduced inside the aseptic area.
  • Serve as escort during internal audits associated with the Compliance department.
  • Support OpExinitiatives.
  • Other duties as assigned by supervisor.

Qualifications

High School diploma.  AS in science or related field.  Detail oriented, highly organized. Able to maintain confidentiality.  Effective written and verbal communication skills. Possess interpersonal skills, time management and follow through abilities. Effective problem solver with solid leadership abilities.

10+ years pharmaceutical cleanroom experience, program management, thorough knowledge of proper aseptic techniques, training course design and delivery, knowledge of cGMPs.

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