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Senior QC Analyst

Job description

Senior QC Analyst - Start-up - Biologics

Job Responsibilities

-Design and implementation of quality systems in the QC lab.

-Integrated involvement with other personnel in Document Review, SOP generation and analytical procedures.

-Equipment Calibration & Maintenance, Reference Standard Management, Auditing, LIMS, and maintenance of Lean Lab Techniques.

-Liaise with other analyst with relation to scheduling and result review of their work.

-Sampling and analytical testing of raw material of master cell stock, drug substances and drug products in accordance to procedures and plant schedules.

-Review and/or carry out of method transfer and method validation protocols and reports in accordance to project deadlines.

Essential Job Requirements

-BSc Degree (life science).

-4 years in GMP/GLP regulated environment.

-HPLC and its troubleshooting.

-Practical experience in relation to cell work is desirable, such as, counting, morphology evaluation, and flow cytometry.

-Method transfer/validation

-Experience in working in Biologics Facility - desirable, but not essential.

Should you be the qualifying candidate and are interested in this job, please contact Andrius at (01) 4744 692 or at aantanaitis@sigmar.ie

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