Lead Senior QC Micro Analyst

Regeneron

Limerick, Ireland

Within this role you will be responsible for performing testing to ensure cGMP compliance in the manufacturing facility also assessing the microbiological quality of products, manufacturing equipment, manufacturing process areas, and facility utilities.

This is a shift-based position (extended days).

Lead-Related Activities include, but are not limited to, the following:

Providing on-the-floor guidance and support to employees;
Ensuring employees' timesheets are completed on time;
Monitoring employee training to ensure that all requirements are met, including OJT;
Maintaining up to date training records for self and direct reports;
Performing monthly performance feedback meetings with direct reports;
Escalating all performance issues to management and/or HR.

As a Lead Sr QC Micro Analyst, a typical day might include, but is not limited to, the following

Representing Micro and participating in cross functional site meetings;
Administration of programs such as gowning, training, ordering, calibration, etc.;
Technical writing assignments such as SOPs, protocols, final reports, trend reports, risk assessments, laboratory investigations, etc.;
Participating in training of other new employees and prioritizes workloads on a daily basis;
Performing peer review of data;
Performing laboratory investigation reports;
Performing microbial identification procedures;
Maintaining laboratory supplies, media, and reagents inventory;
Participating in the overtime and weekend schedule as required;
Performing bioburden and endotoxin testing of products and raw materials;
Performing microbiological testing of in-process and final product materials;
Performing biological and endotoxin indicator testing used in the validation of manufacturing equipment;
Updating microbiological environmental monitoring results database and prepares monthly report;
Performing acceptance testing of commercially prepared microbiological culture media;
Assisting in coordinating equipment maintenance and calibration;
Using Laboratory Information Management System (LIMS) for sample and sample test result tracking;
Performing all duties relevant to the Quality Control Microbiology Analyst position as required.

To be considered for this opportunity you should have a BS/BA in Microbiology or related field and 5+ years of relevant experience, or equivalent combination of education and experience.

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