QC Biochemist

Overview Description QC Biochemist

The Opportunity
The QC Biochemist will be responsible for supporting operations through completion of all testing required (e.g., receipt, in-process, finished and stability product testing), report writing, writing procedures, management of systems and training. The role will also have responsibility for tasks associated with analytical method validation (technical transfer and pharmacopeial method validation).

Key Responsibilities

Perform tasks in accordance with Good Laboratory Practices (GLP) and Good Manufacturing Practices (GMP), ensuring safety compliance in the laboratory and facility.

Manage analytical technical transfers, qualification of Pharmacopeial methods, and laboratory instrumentation qualifications.

Oversee product testing, trend reports, and all associated activities; troubleshoot instruments and write reports/procedures.

Train personnel on biochemical testing processes and document results in LIMS, ensuring peer review.

Handle incident reports, non-conformances, CAPAs, OOS investigations, and lead QC process improvement projects.

Author and update laboratory policies, procedures, and data trending, including Continuous Process Verification.

Essential Knowledge & Experience

Proficient in laboratory technologies including LIMS, SAP, Empower, and TrackWise.

Extensive experience with instrumentation such as icIEF, Capillary Electrophoresis, Liquid Chromatography (ELS, TUV, FLR detectors), Polarimetry, and Moisture content analysis.

Solid understanding and experience in completing Pharmacopeial testing.

Education

B.S. degree in Chemistry/Microbiology with relevant industry experience in a Quality Control lab.

Additional Information

This is a permanent full-time position

Position is based in Tralee – Ireland

This position requires you to be 100% on site / in the office

We are an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, colour, religion, sex, national origin, disability status, protected veteran status, or any other characteristic protected by law.

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