Senior Quality Specialist; Laboratory

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Requisition

Date:
Oct 2, 2026

Location:

Greenfield, IN, US, 46140

Department:
Quality

Description:

This is an onsite position requiring the team member to be onsite 5 days a week.
No relocation is provided for this opportunity.

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.

The Senior Quality Specialist (Laboratory) provides quality systems oversight and customer-focused quality support for West Services & Solutions, Metrology, and Laboratory operations at West, Indiana. This role supports the implementation, maintenance, and continual improvement of Quality Management System processes; drives timely closure of internal and external quality issues; and supports compliance, audit readiness, customer requirements, and operational performance. The role collaborates with cross-functional teams, WSS, Metrology, Laboratory personnel, site QA, Corporate QA, and applicable West network functions to ensure corporate, regulatory, GMP, ISO, compendial, and customer quality requirements are consistently met.

• Establish, implement, maintain, and continually improve quality and technical standards for WSS, Metrology, and Laboratory operations at West, Indiana to ensure products and services consistently meet customer, regulatory, ISO, GMP, compendial, and West requirements.
• Ensure an effective Quality Management System is maintained for WSS, Metrology, and Laboratory operations in accordance with West policies and procedures and applicable regulatory requirements.
• Provide QA oversight, governance, training, coaching, and guidance for assigned QMS processes, including CAPA, deviations, change control, document control, investigations, complaints, calibration, audit readiness, and quality record closure.
• Lead investigations for assigned areas of process ownership and provide QA oversight and support for WSS, Metrology, and Laboratory investigations, ensuring appropriate root cause analysis, containment, corrective actions, and preventive actions.
• Lead and support risk management activities, including risk assessments, risk analysis, adverse trend identification, escalation of systemic quality risks, and implementation of appropriate control plans.
• Prepare, review, and present routine metrics, KPIs, reports, trend data, and improvement opportunities for WSS, Metrology, and Laboratory operations to support operational oversight and timely decision-making.
• Conduct and support formal Quality Management Review activities, including scheduling, data collection, reporting, presentation of key quality information, maintenance of required statistics, escalation of trends, and communication of performance outcomes.
• Support…