QC Analyst (Bioassay)

QC Analyst (Bioassay)

Regeneron

Limerick, Ireland

Job Description

Within this role you will perform a wide variety of bioanalytical processes to support bulk drug substance manufacture in a cGMP regulatory environment.

As a QC Analyst within the Bioassay Lab, a typical day might include, but is not limited to, the following:

• Ensuring that all work carried out is in compliance with current GMP, the required regulatory standards, conforming to company policies and standard operating procedures (SOPs);
• Reviewing data from other analysts for accuracy and completeness;
• Performing bioassays in line with cGMP practices;
• Sub-culturing mammalian cell lines and performing cell counts;
• Maintaining laboratory reagents and supplies;
• Preparing reagent aliquots and media for use in cell-based assays;
• Maintaining equipment in the laboratory;
• Conducting laboratory investigations and generating reports in response to invalid assays, deviations, OOS/OOT;
• Initiating and completing CAPAs in accordance with site procedures;
• Writing new and updating current SOPs as needed;
• Presenting bioanalytical data reports clearly and concisely to management;
• Identifying and implementing lab process improvements and lean initiative;
• Performing any other duties relevant to the QC laboratory position as the need arises.

This role might be for you if

• You have current or prior experience working with Bioassay's;
• 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;
• You have worked with molecular biology and cell biology techniques such as ELISA, Bioassay and mammalian cell culture.

To be considered for this opportunity you must hold a BS/BA in Life Sciences or related field or an equivalent combination of education and experience with 2+ years experience working in a regulated testing environment. Previous experience working in Biotech environment is a distinct advantage.

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