Cpl in partnership with their client Pfizer. Are recruiting for an QC Analyst (Potency) for their Grange Castle site.
To perform all activities related to the Potency lab to enable the routine maintenance of the day to day running of the lab.
- 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 Passaging of both adherent and suspension cell lines
- 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.
cell culture, quantitative assays, small volumes, pipetting