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CAPA Investigation Specialist - q8MH2KjIoYur-6411
CAPA Investigation Specialist - q8MH2KjIoYur-6411-April 2024
Lenexa
Apr 2, 2026
About CAPA Investigation Specialist - q8MH2KjIoYur-6411

  This job was posted by https://www.kansasworks.com : For moreinformation, please see: https://www.kansasworks.com/jobs/12813466Provide consulting services in aseptic processing. The consultant willperform investigations as relates to sterile manufacturing processesthat utilize Isolator technology. Client is requiring isolatortechnology and aseptic fill experience. Work on a team under a SeniorManager. Min 7 years experience. Isolator experience helpful. Excellenttech writing skills in investigations needed.

  Report Frequency

  Weekly reports on activities performed during the week andrecommendations/actions for at risk activities.

  Monthly report on areas found for opportunities to improve in theaseptic process area with recommendations.

  End of project summary report for all improvement activities.

  Weekly Activities

  Perform operations assessments of the Aseptic Processing to identifygaps and areas of improvement.

  Immediately notify management for any potential gap identified asapplicable.

  Review procedures such as policies, master batch records, executedprotocols/reports, plans, etc.., and any applicable referenced materialthat may present enhancement opportunities.

  Assist in the revamping/development of the Aseptic OperationsCertification Program, or other related activities as assigned bymanagement.

  Review any applicable Change Controls, CAPA, and Investigations, forbetter understanding of the Aseptic Processing issues detected.

  LOCAL TO BALTIMORE CANDIDATES ONLY *

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