CAPA Investigation Specialist

4 weeks ago

Lenexa, United States Compli Full time
Job DescriptionJob Description

Provide consulting services in aseptic processing. The consultant will perform investigations as relates to sterile manufacturing processes that utilize Isolator technology. Client is requiring isolator technology and aseptic fill experience. Work on a team under a Senior Manager. Min 7 years’ experience. Isolator experience helpful. Excellent tech writing skills in investigations needed.

Report Frequency

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

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

End of project summary report for all improvement activities.

Weekly Activities

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

Immediately notify management for any potential gap identified as applicable.

Review procedures such as policies, master batch records, executed protocols/reports, plans, etc.., and any applicable referenced material that may present enhancement opportunities.

Assist in the revamping/development of the Aseptic Operations Certification Program, or other related activities as assigned by management.

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

LOCAL TO BALTIMORE CANDIDATES ONLY *

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