Quality Assurance Specialist - ATP Monitoring (Neogen Clean-Trace)

Job Summary
We are seeking a highly motivated and detail-oriented Quality Assurance Specialist focused on ATP (Adenosine Triphosphate) Monitoring for Neogen’s Clean-Trace system. In this role, you will ensure the integrity and compliance of our manufacturing processes by implementing rigorous quality assurance protocols, conducting precise ATP testing, and maintaining adherence to industry standards such as ISO 13485, FDA regulations, and cGMP guidelines. Your proactive approach will help uphold the highest quality standards in our products, ensuring safety and efficacy for our customers. This position offers an exciting opportunity to contribute to cutting-edge quality systems within a dynamic manufacturing environment dedicated to excellence.

Responsibilities

• Perform ATP monitoring using Neogen’s Clean-Trace system to verify cleanliness and sanitation levels across manufacturing lines.
• Conduct thorough quality inspections utilizing precision measuring instruments such as calipers, micrometers, and vision inspection systems to ensure product conformity.
• Lead and participate in quality audits aligned with ISO 9001, ISO 13485, and FDA regulations to identify areas for improvement and ensure compliance.
• Collect and analyze data related to quality control processes, documenting findings accurately for review and continuous improvement initiatives.
• Coordinate measuring machine (CMM) inspections and utilize calibration tools to maintain measurement accuracy across all quality assurance activities.
• Support manufacturing teams by providing real-time feedback on quality issues, facilitating root cause analysis, and implementing corrective actions within established quality systems.
• Assist in maintaining comprehensive records of inspections, audits, calibration logs, and non-conformance reports to support regulatory compliance and internal assessments.

Experience

• Proven experience in a manufacturing or quality assurance environment, preferably within the medical device or pharmaceutical industry.
• Strong knowledge of ISO 13485, FDA regulations, cGMP practices, HACCP principles, and ISO 9001 standards.
• Hands-on experience with Calypso software or similar quality management systems is highly desirable.
• Skilled in using precision measurement tools such as calipers, micrometers, vision inspection systems, and coordinate measuring machines (CMM).
• Demonstrated ability to perform detailed data collection, analysis, and reporting related to QA/QC processes.
• Familiarity with conducting internal or external quality audits and implementing continuous improvement strategies within a regulated environment.
• Excellent attention to detail combined with strong communication skills to effectively collaborate with cross-functional teams. Join us in driving excellence through rigorous quality assurance practices! Your expertise will help ensure our products meet the highest safety standards while supporting innovation in our manufacturing processes. We value proactive problem-solvers who thrive in fast-paced environments dedicated to continuous improvement and customer satisfaction.

Job Types: Full-time, Temp-to-hire

Pay: $18.00 - $22.00 per hour

Benefits:

• 401(k)
• Dental insurance
• Flexible schedule
• Health insurance
• Paid time off
• Vision insurance

Work Location: In person