Lead QC Micro Analyst

Regeneron

Limerick, Ireland

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

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 employees' training to ensure that all requirements, including OJT, are met;
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 Micro QC Analyst, a typical day might include, but is not limited to, the following:

Providing microbiology representation and participation in cross-functional site meetings;
Administering programs such as gowning, training, ordering and calibration;
Conducting technical writing assignments such as SOPs, protocols, final reports, trend reports, risk assessments, laboratory investigations, etc.;
Training other new employees and prioritizing workloads on a daily basis;
Reviewing peer data;
Investigating laboratory reports;
Identifying microbial procedures;
Maintaining laboratory supplies, media, and reagents inventory;
Participating in the overtime and weekend schedule as required;
Testing bioburden and endotoxin of products and raw materials;
Testing microbiological of in-process and final product materials;
Testing biological and endotoxin indicators used in the validation of manufacturing equipment;
Updating microbiological environmental monitoring results database and preparing monthly reports;
Testing for acceptance of commercially prepared microbiological culture media;
Coordinating equipment maintenance and calibration;
Utilizing 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.

This role might be for you if:

You have a proven ability to work independently or as part of a team;
You possess strong trouble-shooting and problem solving skills;
You have strong attention to detail & excellent written and oral skills.

To be considered for this opportunity you should have a BS/BA in Microbiology or related field and 1+ years of relevant experience or equivalent combination of education and experience.

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