Quality Assurance Supervisor

Overview

At West, we’re a dedicated team that is connected by a purpose to improve patient lives that has been at the center of our Company for more than a century. Our story began when Herman O. West solved the problem of supplying penicillin in mass quantities to the US Government during World War 2. Through our work to deliver thousands of life-saving and life-enhancing injectable medicines to millions of patients daily, West’s indelible mark on the healthcare industry has just begun.

A name started our story. How will yours help write our future?

There’s no better place to join an inclusive community of professionals with opportunities for lifelong learning, growth and development. Supported by benefit programs, we empower the physical, mental, emotional and financial health of our team members and their families.

We believe in giving back to help those in need in the communities where we live and work. And are equally committed to creating a healthier environment and planet through our sustainability efforts.

Supervisor, QA, Kearney — This Full-time onsite role will supervise, coordinate and administer the site Quality Control systems compliance:
Document Control, Nonconformance/Deviation Reports, OOS Process, Measurement Systems, Change Control, Calibration and CAPAs. Supervise and support internal projects and ensure cGMP compliance, applicable ISO requirements, company policies and procedures.

• Qualify inspectors to independently perform responsibilities for competency/proficiency capabilities in inspections, measurements, sampling, Quality audits and defect recognition.
• Qualify and/or support qualification of team members for competency/proficiency in defect and quality incident recognition/escalation.
• Train inspectors in deviation/non-conformance/OOS record initiations, escalations, how to perform containment/bracketing, and initial event triage activities.
• Ensure deviation/nonconformance reports and OOSs are completed properly, including root cause investigation (if required), effective corrections and actions closed within an established goal.
• Monitor and enforce compliance to a high level of work standards across the QC functions. Ensure that jobs are carried out efficiently. Paperwork is maintained accurately in accordance with Company policies, Regulatory standards and Training.
• Perform various SAP transactions for maintaining proper product disposition for release criteria and inventory control.
• Analyze data and provide reports/recommendations to Management for continuous improvement.
• Submit periodic reports on the status of compliance to Quality System requirements.
• Review Customer specifications and ensure requirements are translated into site procedures and documentation as needed.
• Provide for Quality planning by preparing inspection plans and documentation controls.
• Support facilities, equipment and process validations. Approve engineering studies and other protocols as required.
• Ensure proper completion of Change Controls and monitor timely completion when required.
• Monitor completion of MSA’s for critical measurement systems and provide recommendations for gauging improvements.
• Provide expertise and guidance for statistical methods in Production.
• Conforms with and abides by all regulations, policies, work procedures, instructions and all safety rules.
• Performs other duties as assigned based on business needs.
• Exhibits regular, reliable, punctual and predictable attendance.
• Other duties as assigned

• High school Diploma required.
• Bachelor's degree in Quality, Engineering, Science or equivalent experience preferred.

• Minimum of 3 years of related experience analyzing information, documentation skills, promoting process improvement and safety management.
• Minimum 1 year of leadership experience or demonstration of leadership skills routinely as part of previous/current role(s).

• Demonstrate a high degree of proficiency in Excel, Word and other Microsoft Office Programs required. Demonstrate oral and written communication skills.
• Familiarity with a variety of Quality concepts, practices, AQL…