Job Description
Job Purpose
The QA Specialist III position will advance LGC purpose of understanding disease to enable precision diagnostics by supporting and contributing to LGC’s product quality and Quality Management System processes. The successful candidate will have a strong orientation toward continuous improvement and the ability to act as a role model, change agent, and mentor. The ideal candidate will be able to support and collaborate with commercial and manufacturing teams to ensure customer requirements are translated into internal specifications with continuous feedback loops for evaluating product and process performance as well as highly experienced with a working knowledge of quality system requirements, including FDA QSR/cGMP, ISO 13485 and ISO 14971.
Key Responsibilities
Accurately 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 non-conformances, deviations, customer complaints and CAPAs; work with functional groups to determine root causes for process issues related to products and services.
Support activities and documentation related to corrections, corrective actions, and preventive actions to correct and eliminate the potential for non-conformances.
Works constructively with cross-functional departments for timely resolution of quality issues.
Update and track metrics for trending and reporting.
Investigate quality issues and trends from customer complaints, NCMRs, CAPAs, etc. to identify actions required.
Review risk management documentation and actions for completeness, feasibility and adequacy. Track mitigation efforts to reduce medium and high risks to acceptable levels.
Identify improvements to reduce scrap, rework, complaints, and other sources of Cost of Poor Quality (COPQ) in line with quality and cost reduction initiatives.
Review and approve Document Change Requests (DCRs) related to materials, production processes, and test methods.
Initiate SOP changes to streamline, standardize, and improve quality system processes.
Support ongoing product release activities such as review of batch records, QC results, and environmental monitoring records. Assess excursions with appropriate deviations and/or risk evaluations.
Perform internal and supplier audits, issue audit reports, and follow up to close out actions which address the findings.
Provide training and support for quality concepts and tools.
Knowledge, Experience and Technical Skills
Qualifications
Additional Information
All your information will be kept confidential according to EEO guidelines.