Quality Assurance Lead
Bureau Veritas
Knoxville, TN
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Overview
Business Title: Quality Assurance Lead
Position Title: Quality Assurance Specialist V
Division: Consumer Products Services
Entity: Galbraith Laboratories
Reports to: Sr Manager, QHSSE
FLSA: Exempt
Location: Knoxville, TN
Hours Worked: Typically, Monday through Friday, 40 per week
However, must be flexible to meet the needs of the department and complete other projects as assigned.
Major Roles & Responsibilities
External Representation & Regulatory Affairs
Core Competencies
Experience & Educational Background
Business Title: Quality Assurance Lead
Position Title: Quality Assurance Specialist V
Division: Consumer Products Services
Entity: Galbraith Laboratories
Reports to: Sr Manager, QHSSE
FLSA: Exempt
Location: Knoxville, TN
Hours Worked: Typically, Monday through Friday, 40 per week
However, must be flexible to meet the needs of the department and complete other projects as assigned.
Major Roles & Responsibilities
External Representation & Regulatory Affairs
- Lead customer audits independently, and support QA Manager for regulatory inspections & agency visits
- Draft audit responses and corrective action plans
- Monitor regulation changes, assess risk, and close compliance gaps
- Assist with facilitating scope expansion with regulating/certifying bodies
- Participate in cross-departmental corrective activities based on trends
- Support quality event trending and corrective actions
- Facilitate cross-departmental communication
- Improve efficiency and effectiveness of quality processes
- Assist in preparing Management Review Meeting reports
- Report quality systems status to QA Manager
- Develop tracking/trending tools and communicate trends to leadership
- Collaborate with managers on company policies, goals, and procedures
- Oversee CAPA system
- Ensure departmental priorities, goals, and policies are met
- Oversee Quality Assurance Unit policies/procedures
- Approve/reject procedures and specifications for data/client reports
- Review and approve investigations, deviations, and change controls
- Direct inspections and audits for materials, facilities, and test results
- Advise Quality Manager on regulatory strategy and developments
- Resolve client issues to enhance satisfaction
- Lead client audits
- Track deviations, change controls, and complaints
Core Competencies
- Leadership: Lead, develop, and motivate QA teams
- Communication: Exceptional written/verbal skills for executive reporting and stakeholder engagement
- Regulatory Expertise: Deep understanding of requirements and proactive compliance management
- Technical Proficiency: Advanced knowledge of QMS, statistical analysis, and validation
- Expertise in QMS implementation and continuous improvement
- Thorough understanding of ISO 9001, 17025, CFR 210, 211, 820
- Proficient in quality data analysis, trending, and reporting
- Advanced proficiency with QMS software, databases, and statistical tools
- Expert knowledge of GLP, GMP, and regulatory frameworks
- Train and develop QA team on data analysis and quality management
- Strong interpersonal and relationship-building skills
- Oversee large, cross-departmental projects
- Excellent project management and coordination skills
- Advanced problem-solving for complex quality challenges
- Manage multiple high-priority projects simultaneously
- Expertise in root cause analysis and corrective action implementation
- Strong attention to detail with strategic perspective
- Organizational and time management excellence
- Proactively interpret and apply new regulations
- Positive attitude, self-motivated, highly engaged
- Proficiency with Windows, Word, Excel, and specialized quality software
Experience & Educational Background
- Bachelor's Degree + 7 years QA experience with progressive responsibility
- Master's Degree + 5 years QA experience with progressive responsibility
- Laboratory/manufacturing quality management experience
- Regulatory inspection representation experience
- Multiple QMS experience (ISO 17025, ISO 9001, GLP, GMP)
-
Seniority level
Mid-Senior level -
Employment type
Full-time -
Job function
Quality Assurance and Engineering -
Industries
Environmental Services
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