Senior Specialist, Quality Assurance

Role Overview

• This role supports the Quality Management System and overall quality functions for the West Kearney facility, ensuring compliance with ISO standards and cGMP requirements.
• The position drives quality‑focused continuous improvement initiatives, leads or assists with internal and customer audits, and collaborates directly with customers to investigate and resolve product complaints, including intracompany issues.
• Serving as a key member of the site’s Quality leadership team, this role provides clear communication on quality matters and actively participates in quality steering committees across both corporate and manufacturing environments, helping to align quality strategies and support organizational excellence.
• Contribute to the development and implementation of quality management programs focusing on continual improvement across various processes.
• Assists facility with quality improvement programs by utilizing Six Sigma tools and Lean techniques, including the education of facility personnel on these tools and techniques, as necessary.
• Create processes to better evaluate, track and trend audit outputs and identify risks/issues and evaluate impact on global quality systems and initiate actions, as needed.
• Independently perform supplier audits and corporate facility audit, as required.
• Lead or assist in internal, ISO, customer, and corporate quality system audits.
• Assure execution of internal quality audits, according to established procedures for the assigned areas / locations.
• Provide response to audit observations, and customer complaints and inquiries.
• Lead investigation and coordinate response to customer and intracompany complaints to identify and find the root cause of all product and related quality issues, as well as collaborate with site to determine appropriate corrective and preventive actions.
• Support investigation of out of specifications, non-conformance, and/or deviations as necessary to identify and find the root cause of all product and related quality issues.
• Provide leadership and sound decision-making as member of quality management team.
• Lead meetings with customers, employees and contractors as necessary to manage changes.
• Establish/report monthly KPI’s and metrics to Quality Leadership.
• Fill in for Quality Manager as requested or required.
• Perform other duties as required and/or assigned.

Requirements

• Bachelor's degree in Engineering/Science Preferred OR Equivalent Experience in GMP pharmaceutical industry required. (in science, quality, investigations, or engineering role)
• Minimum of 5 years of experience in regulated industry with preferred at least 3 -5 years related experience analyzing information, documentation skills, promoting process improvement and corrective/preventive actions.
• Minimum 1 year of project leadership experience.
• Minimum 1 year investigative experience (DMAIC, A3, 8D, or similar processes).
• Experience with quality systems such as ISO 9001, ISO 15378 and ISO 13485, 21 CFR 820 preferred.
• Experience Leading Internal / External Audits, and SAP preferred and Experience with customer interface and meeting customer expectations preferred.

Benefits

• Community Involvement: West encourages volunteerism through its West without Borders initiative and other charitable programs that make a difference in local communities.
• Continuous Learning & Development: Opportunities for professional growth through training programs, tuition assistance, leadership development, and skill-certification initiatives.
• Inclusive & Collaborative Culture: A global workforce that values diversity, equity, and inclusion—where all voices are heard and respected in a supportive environment.
• Recognition & Rewards: Performance-based bonuses, service recognition, and employee appreciation initiatives celebrate dedication and impact.
• This position offers relocation assistance