Responsible for providing day-to-day quality oversight and technical leadership to support manufacturing operations. Performs quality inspections, process audits, sampling, testing, and quality system activities to ensure products meet established specifications, regulatory requirements, and quality standards. Supports manufacturing operations by providing quality guidance, training, investigation support, nonconformance management, and oversight to ensure compliance with GMP, GDP, and Quality System requirements.
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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
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- 3+ years of Quality Assurance experience - preferred
- Experience conducting inspections, audits, and quality-related activities in a manufacturing environment
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- 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