As a society we should all aim to do our part in helping get an effective vaccine for COVID 19. This organisation is building an incremental testing capacity and are looking for a Senior Manager to direct the team. If you are interested in making an impactful difference, this might be the role for you.
- Be responsible for all aspects of the quality management in our Laboratory operation, encompassing clinical testing, operations and engineering functions
- To support laboratory accreditation to ISO15189/17025 activities (including policy, protocol development, method validation documentation, performance monitoring, maintenance and troubleshooting, data handling and interpretation and reports) and any other future external quality or regulatory requirements for the UK Laboratory.
- Liaise as an independent operator with our Clinical team, Operations and Engineering leading the design and implementation of relevant quality management mechanisms. Closely collaborate with the quality management team in other Amazon laboratories
- Lead daily quality KPI monitoring and reporting
- Schedule and perform assigned laboratory audits and ensure timelines for audit steps (pre-work, conducting audit, issuance of audit report, corrective action and preventive action receipts) meet established expectations. Maintain industry current knowledge, application, and certification status for various technical and quality auditing topics.
- Maintain broad-based expertise of cGLP's, industry policies, procedures and guidelines, regulatory requirements, etc. that are pertinent to laboratory testing of human samples.
Skills and Requirements
- Bachelor's Degree in Science, Chemistry, (Micro-) Biology, Engineering or equivalent.
- Experience driving UKAS accreditation of diagnostic laboratory facilities, operating at CL2 or above. Thorough understanding of Quality Management Systems (i.e ISO 17025, ISO 15189) and current awareness of regulatory expectations and requirements for a diagnostic laboratory in UK.
- Quality auditing experience.
- Experience with Bio-Safety requirements for clinical labs and clean room experience.
- Fluency in Lean Manufacturing, Manufacturing Process Control and/or Six Sigma.
- Strong compliance knowledge and proficiency in interpreting and applying regulatory requirements and guidelines
Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.