Job Purpose
The Senior Quality Specialist position will advance LGC Clinical Diagnosticsâ purpose of Science for a Safer World by supporting and contributing to TNACâs product quality and Quality Management System processes. LGC Clinical Diagnosticsâ 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.