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Sterilisation Analyst Career Profile

Sterilisation Analyst

Usually within a Medical Device facility, a sterilisation Analyst will have responsibility thay product output is sterilised correctly and to the appropriate level as required by Corporate and notified body Quality Standards. There are a number of sterilisation mthods used in industry, and these generally vary depending on product or exact manufacturing facility. A sample spec is below:

  • Lead the Quality Assurance Technicians that work within Sterilisation. Maintain the process flow for the sterilization batch review which will include interactions with Incoming Inspection, Receiving, the Manufacturing Sites and the Contract Sterilisers.Perform inspection activities for all products sterilized by contract sterilizers or in-house sterilisation services.To perform inspection activities, including batch record review for all products sterilized by contract sterilisers or in-house sterilisation services.
  • Ensure completion of nonconforming reports within the eCAPA system which includes maintenance of logs and metrics associated.Interface with plant representatives and external functional groups regarding nonconforming issues.Perform the review and approval of all sterilization batch records to ensure that all processing parameters have been met according to specification.
  • Revise standard operating procedures and templates used to review and approve sterilisation processing records.Assist the Manager with setting priorities for the daily expedites.Track the schedule for biological indicator testing and contact the contract sterilisers to expedite the test result reviews.
  • Review, analyzes and reports on quality discrepancies related to Sterilisation.Investigates problems and develops disposition and corrective actions for recurring discrepancies.Interfaces with manufacturing, engineering, customer, vendor and subcontractor representatives to determine responsibilities.
  • Education and Training BSc / BEng degree, or equivalent education and experience.
  • -3 to 5 years Experience in a Quality Control/ Quality Assurance Function.
Knowledge and experience of the following is usually desirable:
  • Ethylene Oxide sterilisation (EtO sterilisation)
  • Moist Heat sterilisation / Steam sterilisation
  • Filtration sterilisation
  • Gamma sterilisation