Quality Assurance Specialist

Essential Duties

• Review and approve quality and product-release records, including batch records, QC results, environmental monitoring records, and related documentation, to verify compliance with internal specifications, customer requirements, procedures, and established standards
• Independently investigate quality issues, nonconformances, deviations, and customer complaints; partner with cross-functional teams to determine root cause and identify appropriate actions to address product and process concerns
• Initiate and support Corrective and Preventive Actions (CAPAs), including documenting investigations, determining appropriate corrections and corrective actions, monitoring implementation, and supporting timely and effective resolution of quality issues
• Review quality data and metrics to identify trends, recurring issues, and emerging risks, and recommend actions to improve product quality, process performance, and overall Quality Management System effectiveness
• Investigate quality issues and trends from customer complaints, NCMRs, CAPAs, and other quality records
• 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 new product development and design-control activities by participating in cross-functional reviews and completing assigned Quality Assurance deliverables to ensure quality requirements are incorporated throughout product development
• 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
• Support New Product Development to include attending design control meetings and completed Quality Assurance Deliverables
• Support and Host External Audits
• Perform other duties as required, or assigned by management, to meet business needs

Essential Knowledge and Qualifications

• Associate's degree in a Technical, Scientific, Quality, or related field — or equivalent combination of relevant education and applicable work experience
• 5+ years of experience in a cGMP or regulated environment, eg. governed by ISO 9001, or ISO 13485
• 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

Desired Knowledge and Qualifications

• Prior experience in the medical device, biotechnology, or biopharma industry
• Prior experience in an ISO or FDA-certified manufacturing environment
• Demonstrated experience with electronic platforms for quality management systems
• Proficient computer skills, including working knowledge of Microsoft Office suite of products, particularly Word, Excel, and PowerPoint

Behavioural and Interpersonal Competencies

• Resonate and operate in line with LGC's core value behaviors: Passion, Curiosity, Integrity, Brilliance, and Respect
• 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 independently in a home-based environment with minimal supervision, while maintaining accountability for deadlines and communicating progress
• Strong interpersonal, organizational, verbal and written communication skills
• Demonstrates curiosity, adaptability, and commitment; collaborates effectively with geographically distributed teams and actively builds relationships through virtual communication
• 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