Quality Assurance Technician

Roles & Responsibilities

Quality Oversight & In-Process Activities

• Perform in-process inspections, audits, sampling, and testing per approved procedures, specifications, and sampling plans
• Monitor manufacturing processes through routine quality audits and observations for compliance
• Conduct quality inspections using approved methods, equipment, and techniques
• Perform raw material inspections to verify compliance with specifications
• Verify finished products meet applicable specifications prior to release or disposition
• Ensure proper handling, identification, and traceability of materials, samples, and quality records

Leadership & Training

• Provide day-to-day guidance and technical support to QA Technicians and manufacturing personnel
• Assist with onboarding/training of QA Technicians and production associates on quality requirements, inspection methods, sampling practices, GMP, and GDP
• Support qualification and ongoing competency assessment of personnel performing quality activities
• Serve as a quality resource promoting compliance and quality awareness

Deviation Management, Investigations & Escalation

• Identify, document, and escalate nonconformances (NCR/QNs), deviations, and abnormal conditions
• Support containment, investigation, and disposition of nonconforming materials/products
• Collaborate with Manufacturing, Engineering, and cross-functional teams on root cause analysis
• Assist with implementation and follow-up of corrective/preventive actions
• Provide timely communication and escalation of quality concerns to leadership

Quality Systems & Continuous Improvement

• Support development, revision, implementation, and maintenance of quality procedures, work instructions, and forms
• Support compliance with Quality Management System requirements through audits and monitoring
• Maintain accurate, complete, contemporaneous quality records per GDP
• Support internal/external audits, regulatory inspections, and audit readiness activities
• Perform statistical analysis, trending, and evaluation of quality data; communicate findings to management
• Prepare and maintain quality metrics, reports, and summaries

Compliance & Documentation

• Ensure compliance with GMP, GDP, company policies, and regulatory requirements
• Execute activities per approved SOPs, Work Instructions, and specifications
• Maintain required training qualifications and certifications
• Support data integrity, documentation accuracy, and record retention

Safety & Compliance

• Demonstrate compliance with site safety requirements and support safety initiatives
• Maintain required safety training and certifications
• Perform other duties as assigned to support business needs

Experience Required

• 3+ years of Quality Assurance experience – preferred
• Experience conducting inspections, audits, and quality-related activities in a manufacturing environment

Skills & Certifications

• Working knowledge of cGMP, GDP, Quality Systems, and regulatory requirements
• Strong analytical, problem-solving, and troubleshooting skills
• Proficiency in Microsoft Office, particularly Excel
• Interpreting specifications, procedures, and technical documentation
• Strong communication, organizational, and leadership skills
• Identifying, evaluating, and escalating quality issues

Eligibilities & qualifications

• High school diploma/GED required
• Associate degree or technical degree in a scientific, technical, or related discipline – preferred