Senior Quality Specialist, Laboratory

West Pharmaceutical Services

. Establish, implement, maintain, and continually improve quality and technical standards for WSS, Metrology, and Laboratory operations .

Posted 10/2/2026full-timeGreenfield • United StatesSeniorWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in Quality Assurance and Quality Management Systems, with a strong focus on regulatory compliance, risk management, and continuous improvement methodologies. Proficient in leading investigations, conducting audits, and managing quality documentation in a regulated environment.

Highest-signal resume keywords

Quality Assurance ExperienceISO 13485 KnowledgeRoot Cause AnalysisCAPA ManagementRegulatory Audit Support

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Quality Management SystemRoot Cause AnalysisRisk AssessmentCAPAChange ControlDocument ControlQuality MetricsTrend ReportingLaboratory Data ReviewValidation Lifecycle Activities

Soft Skills

Effective CommunicationPlanning and PrioritizationIndependent WorkEscalation of Risks

Tools & Technologies

LIMSSAPMasterControlSharePoint

Industry Keywords

GMP21 CFR Part 82021 CFR Part 210/211Medical DevicePharmaceuticalLife SciencesQuality SystemsMetrologyLaboratory Quality

About the role

Key responsibilities & impact

Establish, implement, maintain, and continually improve quality and technical standards for WSS, Metrology, and Laboratory operations
Maintain an effective Quality Management System in accordance with West policies and applicable regulatory requirements
Provide QA oversight, governance, training, coaching, and guidance for QMS processes
Lead investigations and ensure root cause analysis, containment, corrective actions, and preventive actions
Lead and support risk management activities, risk assessments, trend identification, and systemic risk escalation
Prepare, review, and present metrics, KPIs, reports, trend data, and improvement opportunities
Conduct and support formal Quality Management Review activities
Support regulatory responses, customer information requests, and inspection readiness
Plan, host, coordinate, and support customer, ISO, Corporate QA, regulatory, and internal audits or inspections
Participate in developing, reviewing, approving, and improving procedures, work instructions, forms, validation inputs, protocols, laboratory methods, metrology procedures, and quality processes
Review and approve laboratory, metrology, and WSS quality documentation and records, including LIMS/SAP records and data integrity records
Partner with QA management, site and Corporate QA, cross-functional teams, customers, West sites, and regulatory or audit stakeholders
Contribute to ramping up a state-of-the-art manufacturing facility

Requirements

What you’ll need

High School diploma or equivalent required
5+ years experience in Quality Assurance, Quality Systems, Laboratory Quality, Metrology, manufacturing, or a regulated medical device, pharmaceutical, combination product, or life sciences environment
Bachelor's degree in Engineering, Science, Quality or a related field preferred
Equivalent combination of education and/or relevant work experience will be considered
Working knowledge of ISO 13485, 21 CFR Part 820 QMSR, 21 CFR Part 210/211, and GMP
Experience with CAPA, deviations, change control, document control, investigations, complaints, calibration, audit readiness, and quality record closure
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, Validation Master Plans, protocols, reports, verification/validation activities, and risk management expectations
Experience supporting internal, external, customer, ISO, Corporate QA, or regulatory audits/inspections
Experience reviewing quality, laboratory, metrology, or WSS documentation and 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
Ability to work onsite 5 days a week
Ability to travel up to 5% (up to 13 business days per year)
Sedentary physical requirements, including occasionally lifting, carrying, pushing, pulling, or moving up to 10 lbs/4 kgs

Benefits

Comp & perks

Community involvement through West without Borders and other charitable programs
Professional growth through training programs
Tuition assistance
Leadership development
Skill-certification initiatives
Opportunities for international exposure and cross-functional collaboration
Inclusive and collaborative culture valuing diversity, equity, and inclusion
Performance-based bonuses
Service recognition
Employee appreciation initiatives
Employee accommodation support where permitted by law