Analysis Skills, Change Control, Code of Federal Regulations, Continuous Improvement, Corporate Policies, Corrective Action, Corrective and Preventative Action (CAPA) Systems, Customer Relations, Customer/Client Research, Data Analysis, Detail Oriented, GLP (Good Laboratory Practices), GMP (Good Manufacturing Practices), ISO (International Organization for Standardization), ISO 9001, Interpersonal Skills, Laboratory, Leadership, Maintain Compliance, Management Strategy, Manufacturing Management, Material Audit, Microsoft Excel, Microsoft Windows Operating System, Microsoft Word, Monitor Regulations, Multitasking, Organizational Skills, Problem Solving Skills, Project/Program Management, Quality Assurance, Quality Management, Regulations, Regulatory Compliance, Resolve Customer Issues, Risk Analysis, Root Cause Analysis, Statistics, Status Reports, Testing, Time Management, Trend Analysis, Writing Skills
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
- 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
Strategic Management
- 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
Reporting & Oversight
- 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
Advanced Technical Authority
- 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
Client Relations
- Resolve client issues to enhance satisfaction
- Lead client audits
- Track deviations, change controls, and complaints
Knowledge, Skills & Abilities
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
Technical Skills
- 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
Management & Leadership
- 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
Analytical & Problem-Solving
- 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
Additional Competencies
- 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
Required Qualifications:
- Bachelor''s Degree + 7 years QA experience with progressive responsibility
OR
- Master''s Degree + 5 years QA experience with progressive responsibility
Preferred:
- Laboratory/manufacturing quality management experience
- Regulatory inspection representation experience
- Multiple QMS experience (ISO 17025, ISO 9001, GLP, GMP)
Compensation Range: $75,000 - $90,000 annually (e.g., the job posting is not necessarily reflective of actual compensation that may be earned, and actual compensation is subject to variation due to such factors as locations, education, experience, and skillset)