QC Analyst - Potency
- Dublin, (IRL), Cork, (IRL), Dundalk, (IRL), Dunboyne, (IRL), Galway, (IRL), Kildare, (IRL)
- Negotiable
- Permanent
- Start date: ASAP
- Ref: AF5080963RERUN
- cell line
- QC
- Potency Assay
- PCR
- lims
Job description
Posted 20 July 2021
QC ANALYST – POTENCY
Company introduction:
Our Global Biopharmaceutical client is currently looking for a number of QC Analyst – Potency.
The Quality department is an expanding and diverse team currently comprised of ~500 people, over 12 different areas each with a multitude of high performing teams across both QA and QC.
You will contribute to the safe operations of QC Laboratories, support QC testing, transfers and projects for both established and upcoming new products and facilitate and assist with laboratory investigations.
The 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
