Job Description Job Purpose The Senior Quality Specialist position will advance LGC Clinical Diagnostics’ purpose of Science for a Safer World by supporting and contributing to TNAC’s product quality and Quality Management System processes. LGC Clinical Diagnostics’ TNAC Kidlington location is seeking a candidate who is experienced with a working knowledge of quality system requirements to ISO 9001. The successful candidate will have a strong orientation toward continuous improvement. Key Responsibilities Provide direction and guidance to the TNAC team in execution of and compliance with the Quality Management System. Maintain excellent communication with manager and site leadership to ensure quality issues are raised and addressed. Provide and document Quality training of new employees. Accurate review and approval of records comparing results to internal and customer specifications, SOPs, and established standards for product release. Ensure accurate QMS records related to nonconformances, deviations, and CAPAs. Review and approval of protocols, reports, and change management documentation ensuring defendable practices and conclusions. Utilise quality tools to track and trend quality performance and identify key opportunities for improvement. Work with functional groups to investigate quality issues, determine root cause, and suggest and implement corrective and preventive actions. Perform product release activities such as review of labels, batch records, and QC results. Process and approve document change requests followed by providing notification of changes to controlled documents to relevant parties. Perform internal audits, issue audit reports, and follow up to close out actions which address the findings. Promote and contribute to continuous improvement activities. Host audits and regulatory inspections. Provide advice to other departments to ensure compliance with company policies, procedures, and best practices. Provide training on new and existing SOPs and major updates to SOPs and maintain training records. Perform other related duties as assigned by management. Knowledge, Experience and Technical Skills Strong interpersonal, organizational, verbal and written communication skills. Demonstrates curiosity, integrity, brilliance, respect, and passion; works best in a team environment and actively seeks to foster relationships. Ability to ask probing questions to understand unstated expectations and underlying issues, understand competing priorities, and facilitate discussions to gain consensus through the problem-solving process. Oriented to continuous improvement. Impeccable attention to detail.