Skip to Main Content
← Back to Jobs

CAPA/Change control Consultant

OQSIE McPherson, KS
  • Posted: over a month ago
  • Other

Execute corrective actions/preventive actions (CAPA) and change control projects for aseptic improvement projects resulting from regulatory inspections and internal aseptic assessments/audits. Qualified candidates must have sound technical knowledge and experience with pharmaceutical aseptic and sterile manufacturing process development, process improvement, current regulations and regulatory inspections trends, working knowledge of Trackwise/change control systems. Qualified candidate must have ability to own and manage complex change controls and CAPAs resulting from regulatory inspections and internal audits. Working knowledge of the following pharmaceutical systems is preferred: Bosch TL-style filling machines for liquid and lyophilized vials, Bausch & Stroebel cartridge filling machines, IMA vial filling machines (CIP/SIP and single use fluid pathways), steam sterilization autoclaves, sterilization validation, aseptic process simulation (media fills), environmental monitoring in aseptic/sterile manufacturing, process FMEA/risk assessments.

This role is within the McPherson Remediation department, supporting the Aseptic Improvement team. Position will report to Team Leader and work as individual project owner and alongside other Pharmaceutical process engineers and contract engineers on aseptic/sterile manufacturing improvement projects. Successful candidate must have ability to lead complex, technical projects from initial concept/design phase through hands-on ownership of the change control process, and robust implementation of process improvements within aseptic/sterile manufacturing environments.

OQSIE

Address

McPherson, KS
USA

What email should the hiring manager reach you at?

By clicking the button above, I agree to the ZipRecruiter Terms of Use and acknowledge I have read the Privacy Policy, and agree to receive email job alerts.

What email should we contact you at once we get salary info from the hiring manager?

By clicking the button above, I agree to the ZipRecruiter Terms of Use and acknowledge I have read the Privacy Policy, and agree to receive email job alerts.

Our qualification feature is only available to registered members - what email address would you like for us to keep on file?

By clicking the button above, I agree to the ZipRecruiter Terms of Use and acknowledge I have read the Privacy Policy, and agree to receive email job alerts.