Sr. Manager, Microbiology / Microbiology Quality Control Manager

Jacobs Management Group•Kansas City, MO

About The Position

A sterile products manufacturer in the Kansas City area is establishing a senior leadership position to direct site-wide Microbiology and set the direction for sterility assurance and contamination control. This newly created role has site-wide ownership of Microbiology and reports to the Director of Quality. The position partners closely with QA, Manufacturing, and Validation. The role owns the environmental monitoring program and contamination control strategy for classified cleanrooms; leads managers, supervisors, and analysts; and oversees sterility, endotoxin, bioburden, and water testing. It directs investigations of sterility failures, environmental monitoring excursions, and media fill failures through CAPA, and represents Microbiology during regulatory inspections and customer audits.

Requirements

Hands-on experience designing and trending environmental monitoring programs for Grade A/B cleanrooms.
Experience leading environmental monitoring excursion investigations in sterile manufacturing.
Experience supporting media fills, gowning, and isolator qualification.
Experience hosting regulatory inspections.
Be able to perform the job as described.

Responsibilities

Own the environmental monitoring program and contamination control strategy for classified cleanrooms.
Lead a team of managers, supervisors, and analysts.
Oversee sterility, endotoxin, bioburden, and water testing.
Direct investigations of sterility failures, environmental monitoring excursions, and media fill failures through CAPA.
Represent Microbiology in regulatory inspections and customer audits.