Cpl in partnership with their client Pfizer. Are recruiting for an QC Analyst (Potency) for their Grange Castle site.
Job Purpose:
To perform all activities related to the Potency lab to enable the routine maintenance of the day to day running of the lab.
Job Responsibilities:
- Contribute to the operation of QC Laboratories
- Follow and assist in the creation, review and maintenance of SOP’s for cGMP lab test procedures and systems
- Facilitate and assist with laboratory investigations
- Facilitate and assist with corrective action tasks
- Ensure safe operations, attention to detail and good documentation skills according to cGMP
- Perform routine Potency/Cell Culture Tasks including but not limited to
-Performing cell based assays such as cell proliferation and apoptosis assays to support release and stability testing.
-Performing In Vitro Relative Antigenicity Assays to support release and stability testing.
-Preparation and Qualification of Critical Reagents.
-Review of lab testing results.
-Media preparation and reagent qualification
-Establish and Maintenance of Cell Line folders
-Cell Banking and Qualification
-Cell Revival
-Cell Passaging of both adherent and suspension cell lines
-Cell Counting
Waste inactivation
- Assist in the running of the Potency/cell culture lab including weekly ROTA preparation, inventory checks, expiry checks, logbook review, waste maintenance and consumables and stock checks
- Support the management of contract lab testing.
- Support and assist in the introduction of new Cell Lines
- Support the creation of new LIMS builds for new Cell Lines/Assays
- Ensure supply of cells and other critical reagents to external labs as required
- Assist in the maintenance and development of training programs and perform training of other analysts
- Maintain established 5S process and assist in the 5S audits and related activities
- Support and assist the continuous improvement projects and all related CI activities
- Perform and assist in additional duties as directed by the Supervisor.
- Report and document any non-conformances to the Supervisor.
Skills:
cell culture, quantitative assays, small volumes, pipetting