Quality Assurance Technician
MILLENNIUMSOFT
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
- 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
- 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
- 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
- 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
- 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
- 3+ years of Quality Assurance experience - preferred
- Experience conducting inspections, audits, and quality-related activities in a manufacturing environment
- 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
- High school diploma/GED required
- Associate degree or technical degree in a scientific, technical, or related discipline - preferred
Vacancy posted 3 days ago
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