Title:  Senior Specialist, Quality Assurance

What We Offer

Job Summary

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.

Essential Duties and Responsibilities

• 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.

Education

• Bachelor's degree in Engineering/Science Preferred OR
• Equivalent Experience in GMP pharmaceutical industry required. (in science, quality, investigations, or engineering role)

Work Experience

• 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

Preferred Knowledge, Skills and Abilities

• Ability to work independently, multi-task and thrive in fast-paced environment.
• Demonstrate a high degree of proficiency in Excel, Word and other Microsoft Office Programs required.  Demonstrate oral and written communication skills.
• High degree proficiency with problem solving tools, such as fishbone, 5-whys, is/is not, etc.   Demonstrate ability to investigate problems and issues in order to determine root cause analysis.
• Familiarity with a variety of Quality concepts, practices, AQL sampling plans for attribute and dimensional inspection. 
• Able to make independent quality decisions under pressure, if necessary
• Support and contribute in Lean Sigma programs and activities towards delivery of the set target
• Ability to comply with the company’s safety policy at all times
• Ability to comply with the company’s quality policy at all times

License and Certifications

Green Belt Certification Preferred.

Physical Requirements

Additional Requirements

• Adaptable to changes in the work environment, manage competing demands and deal with frequent change, delays or unexpected events.
• Must maintain the ability to work well with others in a variety of situations
• Must be able to multi-task, work under time constraints, problem solve, and prioritize.
• Ability to make independent and sound judgments
• Observe and interpret situations, analyze and solve problems
• Maintain high attention to detail, accuracy, and overall quality of work.
• Effectively communicate and interface with various levels internally and with customers.
• Able to be aware of all relevant SOPs as per Company policy and Quality Manual #LI-NJ1 #LI-Onsite

Shift

Dayshift (on-site)