Job Summary
A skilled microbiologist is sought to establish a laboratory function and develop protocols for Microbiology Test Method Validations, Cleanroom Performance Qualification, Equipment Qualification, Process Cleaning and Disinfectant Qualifications.
Responsibilities
* Develop and create laboratory protocols and procedures.
* Work with the Microbiology team to support and execute all Microbiology activities as per defined schedules and in line with established company procedures and current domestic and international standards ensuring regulatory compliance.
* Review, interpret, and approve results generated from laboratory testing and prepare periodic Microbial testing reports.
* Support the creation and review of Microbiology procedures and documents for accuracy and completeness.
* Assess changes to cleanroom environments by supporting the Equipment Transfer Plan program, performing risk assessments for changes related to the manufacturing process, product development, and product changes.
* Coordinate and support tasks associated with laboratory deviations, OOS events, CAPAs, NCMRs, and COPs.
* Qualify, calibrate, and routine maintain laboratory equipment and their records.
* Support the implementation and use of a laboratory LIMS system.