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Senior Sterility Assurance Specialist

Senior Sterility Assurance Specialist will be responsible for providing technical guidance for Sterilization Management and Sterility Assurance processes (Cleaning Validation, Disinfectant Efficacy, Sterilization, Aseptic Processing) for clients through the development of program, validation and test plans.

  • Develop and maintain systems that insure the technical competency of personnel within the departments.
  • Works with teams to review technical documents, test data, works across all business units, continuously innovates to solve technical issues within all lab functions.
  • Provides technical support during quality inspections, routinely supports Regulatory Affairs and Quality, and remains informed and current on industry standards.
  • Effectively manages laboratory operations to address compliance, customer and business needs in a timely manner. 
  • Meet customer expectations by striving without reserve for the greatest possible reliability and quality in our services.
  • Uses knowledge of industry standards, regulatory guidances, sterilization science, microbiology test methods, aseptic processing, statistics, lean and six sigma principles to assess and provide strategic direction for Sterilization Management and Sterility Assurance program development. 
  • Interacts with clients to discuss project planning and testing issues. Interacts with internal staff to identify assays requiring further improvement or development and oversees improvement of these assays.
  • Oversees and coordinates projects related to the Sterilization Management and Sterility Assurance programs.
  • Function as management review for nonclinical laboratory studies and as a Study Director if needed.

Requirements:

  • Bachelor's Degree in Microbiology or related discipline with 5-years’ experience in a related technical field or equivalent training and/or experience. Minimum of 3-years’ experience in aseptic processing. 
  • Demonstrates a clear understanding of the contract laboratory testing business.
  • Ability to receive and comprehend and to effectively communicate detailed information through verbal and written communication.
  • Ability to evaluate technical data and write technical documents.
  • Ability to accurately and reproducibly perform complex arithmetic calculations and statistics.
  • Ability to make decisions based on a wide knowledge of factors where application of advanced or technical concepts is predominantly required.
  • Excellent problem solving, risk analysis and negotiation skills.
  • Able to travel and work remotely for extended periods of time.

To apply please click on this link:https://home.eease.adp.com/recruit/?id=9490201