Sterilization Validation Specialist

Location: Arroyo, PR
Date Posted: 02-12-2018
Description
The selected resource will be assign to a remediation project in the sterilization area. 

Responsibilities
Assuring and enforcing compliance to sterilization controls regulatory requirements, ensuring the appropriate documentation and procedures are reviewed as per latest regulatory requirements (Gap Assessments), provide advice to other department personnel to ensure resolution of sterility issues for new and existing products (Sterilization Validations), development of protocols and SOP’s, investigations and non-conformities, training to manufacturing areas as production, packaging,logistics and product disposition. Working with functional areas as R&D, Regulatory Affairs, Quality, Microbiology Lab, IT, Operations for the continuous improvement and optimization of current processes.

Qualifications
  • Experience in Sterilization Process (EO preferable), Microbiology, Validations, laboratory process/ investigations.
  • CAPA
  • Microbiology Analysis 
  • Medical Device industry previous experience
 Ultimate Solutions Corp is an equal opportunity employer. 
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