Staff Quality Assurance

About the role

The Staff Quality Assurance provides quality assurance leadership to ensure the integrity of products manufactured, services provided to support business and customer needs, and comply with government regulations, industry and company standards. May develop, maintain, monitor, and audit quality management system and protocols including systems automation, processes, and procedures that ensure compliance with regulations and standards. Will support and may lead audit and inspection preparation, resolution of audit and inspection findings. May be responsible for performance monitoring and will have frequent interaction with other functional areas and operating entities including site leadership.

Responsibilities

• Manage process and product non-conformances in line with company procedures; review, investigate, resolve and report on quality discrepancies
• Support and act as quality assurance lead for product and process validations within the manufacturing site
• Partner with manufacturing professionals to provide QMS guidance and approvals for production deviations, nonconformances, and validation activities, including test method validation and IQ/OQ/PQ
• Support—and, when needed, lead—audit and inspection readiness activities, including the resolution of resulting findings
• Monitor performance and collaborate frequently with cross-functional teams, other operating companies, and site leadership to navigate moderate-complex issues within the quality system

Qualifications

• Bachelor's degree with 8+ years of work experience OR Master's degree with 6+ years of work experience OR Doctoral degree with 3+ years of work experience
• Articulate the risk impact of nonconformances on product quality
• Ability to influence without direct authority and communicate complex / large impact product quality issues in a leadership setting
• Familiarity with test method science and validation principles (IQ/OQ/PQ)
• Ability to travel up to 20%
• Ability to lift, move or carry equipment up to 25lb

Preferred qualifications

• ASQ or accredited certifications in Quality and/or engineering

This position reports directly to the Senior Manager Quality Assurance and is an on-site position at the Hebron, KY Reagent Manufacturing site and a critical part of a large multisite US operations quality organization.