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Search Results for Sterilisation Analyst
Job Title. Location Salary Actions

Sterility Assurance Scientist

We’re currently recruiting for an exciting opportunity with an award-winning Medical Device organization based in Cork. This is an excellent position for anyone who is looking to join a leading multinational who are one of the best at what they do. Duties 1. Assist the International Sterility Assurance Manager in coordinating the activities of a defined team of QA Micro personnel. 2. Supervisory responsibilities include day to day work allocation and prioritization, coaching, training, contribute to performance and output quality review, internal communications an...

Location: Cork,
Sterility Assurance Scientist
Cork Not Disclosed

Sterilisation Analyst Career Profile

Sterilisation Analyst

Responsibilities
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.
Requirements
  • 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