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Form of workJob Description
LGC Clinical Diagnostics Business Unit is comprised of our operating entities including LGC Clinical Diagnostics, Inc. (f/k/a Maine Standards Company & SeraCare Life Sciences), Technopath Clinical Diagnostics and the Native Antigen Company. Our 400+ employees operate FDA-registered and ISO 13485-accredited facilities in Maine (USA), Massachusetts (USA), Maryland (USA), Tipperary (Ireland), and an ISO 9001-accredited facility in Oxford, UK. LGC Clinical Diagnostics is owned by LGC Group, a UK-headquartered life sciences measurement and testing business with >$510m of annual revenue and >3,500 employees globally.
Job DescriptionJob 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
- Experience in root cause analysis and corrective action within a GMP setting.
- Direct audit experience as either a lead auditor or part of the audit team.
- Focused on problem solving, including problem definition, risk evaluation, and risk-based resolution.
- Strong analytical and examination capabilities for complex projects; ability to develop process maps, organize data, evaluate options, document plans, and communicate progress.
- Ability to track and complete multiple priorities in a dynamic environment with minimal supervision.
- Strong interpersonal, organizational, verbal and written communication skills.
- Demonstrates curiosity, adaptability and commitment; 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 with desire to balance the level of control and flexibility in systems based on risk.
- Impeccable attention to detail
- Bachelor’s Degree in a scientific discipline, or Associate’s Degree in a scientific discipline with at least 8 years’ Quality Assurance experience in a serology, immuno-chemistry, and/or molecular biology work environment.
- A minimum of 5 years of experience in a cGMP environment governed by 21CFR210/211, 21CFR820, or ISO 13485.
Additional Information
All your information will be kept confidential according to EEO guidelines.
