Title:  Senior Quality Specialist (Laboratory)

Job Summary

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.

Essential Duties and Responsibilities

• 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 regulatory responses, customer requests for information/documentation, and inspection readiness activities for FDA, ISO, customer, internal, external, and other applicable regulatory inspections or audits.
• Plan, host, coordinate, and support Customer, ISO, Corporate QA, regulatory, and internal audits/inspections for assigned areas, including responses to observations, action tracking, closure, and verification of effectiveness.
• Participate in the development, review, approval, implementation, and continual improvement of procedures, work instructions, forms, Validation Master Plan inputs, validation protocols, laboratory methods, metrology procedures, and quality system processes, ensuring applicable requirements are followed and executed.
• Review and approve applicable laboratory, metrology, and WSS quality documentation and records, including protocols, reports, analytical records, training records, raw data, data integrity records, LIMS/SAP records, method transfers, ESOPs, EWIs, PFNBs, and related quality records.
• Partner with QA management, site QA, Corporate QA, cross-functional teams, customers, West sites, and regulatory or audit stakeholders to support quality oversight, issue resolution, data integrity, compliance, accountability, and continuous improvement.
• Perform additional duties as assigned.

Education

• High School diploma or equivalent required. Bachelor's degree in Engineering, Science, Quality or a related field preferred; equivalent combination of education and/or relevant work experience will be considered.

Qualifications

• 5+ years experience in Quality Assurance, Quality Systems, Laboratory Quality, Metrology, manufacturing, or a regulated medical device, pharmaceutical, combination product, or life sciences environment.

Preferred Knowledge, Skills and Abilities

• Working knowledge of regulated QMS requirements, including ISO 13485, 21 CFR Part 820 QMSR, 21 CFR Part 210/211, GMP.
• Experience supporting core QMS processes such as CAPA, deviations, change control, document control, investigations, complaints, calibration, audit readiness, and quality record closure.
• Strong written and verbal communication skills, with the ability to interface effectively with QA management, cross-functional teams, customers, auditors, and regulatory stakeholders
• Ability to provide QA oversight and governance for WSS, Metrology, and Laboratory operations, including customer/regulatory requests, audit support, data integrity, metrology/calibration compliance, and laboratory/compendial expectations.
• Experience with root cause analysis, risk assessments, corrective and preventive actions, control plans, quality metrics, trend reporting, Management Review inputs, CAPA effectiveness, and continuous improvement methodologies.
• Knowledge of laboratory data review, analytical documentation, method transfer, calibration, metrology systems, LIMS, SAP, MasterControl, SharePoint, or equivalent electronic quality systems.
• Familiarity with validation lifecycle activities, including Validation Master Plans, protocols, reports, verification/validation activities, and risk management expectations.
• Experience supporting internal, external, customer, ISO, Corporate QA, or regulatory audits/inspections, including preparation, response, action tracking, closure, and verification of effectiveness.
• Experience reviewing quality, laboratory, metrology, or WSS documentation and records, including procedures, protocols, reports, analytical/raw data, data integrity records, LIMS/SAP records, training records, and related quality records.
• Ability to plan, prioritize, communicate effectively, present quality information, escalate risks, and work independently in a fast-paced regulated environment.
• Ability to comply with applicable procedures, safety and quality policies, data integrity expectations, and regulatory requirements at all times.

Additional Requirements

• Thrive in a fast-paced environment where teamwork and collaboration drive success.
• Bring a positive, can-do attitude every day as we build and grow together.
• Contribute to ramping up a state-of-the-art manufacturing facility from the ground up.
• Embrace change and innovation as we launch new operations at record speed.
• Work hard, stay flexible, and support your teammates to achieve shared goals.
• Take pride in producing high-quality products that improve patient lives worldwide.
• Live West’s core values of integrity, teamwork, and accountability in everything you do.
• Be part of a culture that celebrates learning, problem-solving, and continuous improvement.
• Show initiative and ownership while helping shape a safe, efficient, and high-performing workplace.
• Grow your career and skillset in a dynamic, innovative environment where your contributions truly matter #LI-JJ1 #LI-ONSITE

Travel Requirements

Physical Requirements

What We Offer

• This is an onsite position requiring the team member to be onsite 5 days a week.
• No relocation is provided for this opportunity.
• 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.
• Global Career Opportunities: With facilities across North America, Europe, and Asia-Pacific, employees have opportunities for international exposure and cross-functional collaboration.
• 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.