Senior QC Analyst (Bioassay) - Days
- BBBH792993 Sep 13, 2021 Competitive
A Senior QC Analyst is required to join a Biologics testing group within a state of the art facility in Dublin.
This Biologics Laboratory tests the group's global Biopharmaceutical products.
As this is a new laboratory this role presents a great development opportunity for someone with the appropriate skills and experience to play their part in the technical set up and development of the laboratory. As the products are manufactured off site, this role is a much sought after days position.
- Support the set-up of the new Laboratory by working with the relevant stakeholders, vendors and suppliers on equipment
- Participate in analytical method transfer/validation to the Bioassay laboratory
- Knowledge and experience in some or all the following is an advantage; Inhibition of Proliferation assay, Potency assays, Binding assay, Maintenance of cell lines for cell-based bioassay, ELISA and Western Blot
- Protocol generation and review - method Transfer / validation
- Creation and revision of training material for the bioassay laboratory
- Lead laboratory investigations to determine root cause and Implement of appropriate corrective and preventative action
- Review and approval of bioassay analytical data
- Ensure that all laboratory operations are carried out in compliance with EHS, cGMP and regulatory commitments
- Participate in risk assessments, inspections, audits, incident investigations, etc. and implement and follow-up on corrective / preventative measures.
- Maintain data integrity and ensure compliance with company SOPs, specifications and cGMP regulations.
- Promote and participate in the implementation and maintenance of relevant safety programmes.
- BSc in Science or equivalent qualification
- Minimum of 3 years relevant experience working with a variety of bioassay and aseptic techniques in a GMP laboratory within the biological and/or pharmaceutical industry.
- Previous experience in the transfer and qualification of Bioassay methods.
- Experience in regulatory audits
- Good working knowledge of QC Systems and Trackwise
Morgan McKinley is acting as an Employment Agency and references to pay rates are indicative.
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