QC Bioassay Specialist
* The motivation to be an inspiring member of a high performing team.
* The desire to continuously learn, improve and develop.
* Perform activities for general lab readiness, laboratory equipment qualification and method transfers.
* Strong knowledge and experience of Bioassay methods.
* Perform and carry out a variety of analytical techniques including but not limited to Potency Elisa test in compliance with GMP requirements.
* Follow up-to-date analytical practices with reference specifications, regulations and industry standards.
* Plan and maintain the laboratory testing schedule to achieve an efficient QC system.
* Maintain good housekeeping and hygiene within the laboratory.
* Participate in risk assessments, inspections, audits, incident investigations, etc. and implement and follow-up on corrective / preventative measures.
* Ensure training is current for all job functions performed.
* Order, stock and receive laboratory supplies.
* Maintain data integrity and ensure compliance with company SOPs, specifications and cGMP regulations.
* Ensure that cGMP standards are maintained at all times.
* Delivery of area performance to meet or exceed performance or quality goals.
* Promote and participate the implementation and maintenance of the relevant safety programmes.
* Participate and Comply with the Quality Management System requirements.
* Responsible for driving a culture of Continuous Improvement by deploying Six Sigma tools.
* Responsible for working with contract lab
* Assist in the "operationalising" of the lab with a strong focus on MPS.
* Train and help develop other analysts within the lab.
* The candidate will be actively supported and encouraged to continue their development and knowledge build, incorporating areas to support their future development and ability to continuously improve in their current role.
*Degree qualification (Science/Quality/Technical). Master preferred.
*3-5 years industry experience with significant knowledge and experience in working in a Bioassay lab unit and working with contract labs
*Experience in Potency Elisa method
*Working knowledge of QC Systems (EN, LIMS) and Trackwise
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