West Pharmaceutical Services

Quality Specialist

• 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

Senior Quality Specialist, Laboratory

QA Engineer

• Provide technical Quality Engineering support for technology transfer, qualification, validation, manufacturing processes, investigations, risk management, and ongoing commercial production
• Apply structured problem-solving, statistical, engineering, and risk-based methods to establish and maintain effective process controls
• Resolve complex product and process quality issues and improve manufacturing performance
• Partner with Operations, Engineering, Validation, Laboratory, Quality Systems, Supplier Quality, and other functions supporting medical device, pharmaceutical packaging, and drug-device combination product programs
• Ensure Quality Engineering activities comply with regulatory requirements, corporate policies, procedures, Quality Agreements, guiding principles, and the Code of Conduct
• Promote Quality ownership, Right First Time execution, continuous improvement, and timely escalation of product quality or compliance risks
• Interface with customers on technical quality matters, including product requirements, investigations, complaints, change controls, validation, risk assessments, and quality performance
• Provide Quality Engineering oversight for technology transfer, new product introduction, scale-up, manufacturing readiness, process performance qualification, and transition to routine commercial manufacture
• Review and approve qualification and validation protocols and reports for equipment, processes, packaging, and computerized systems
• Translate customer and product requirements, Critical to Quality characteristics, and Quality Agreement responsibilities into manufacturing, inspection, and acceptance controls
• Develop, review, and maintain quality specifications, inspection strategies, sampling plans, defect libraries, control plans, and manufacturing control strategies
• Provide technical Quality input to product and process risk management, including PFMEA, risk assessments, control plans, and lifecycle maintenance of risk controls
• Review and approve change controls affecting processes, equipment, facilities, materials, inspection methods, packaging configurations, software, or product quality
• Lead investigations and provide QA oversight, ensuring root cause analysis, containment, corrective actions, and preventive actions
• Develop and assess corrective and preventive actions addressing product, process, systemic, or recurring quality issues
• Analyze manufacturing and quality data using statistical methods to identify adverse trends, assess process capability, and drive sustainable improvement
• Document clear, timely, and risk-based Quality decisions, conclusions, and recommendations while maintaining Quality independence
• Support customer, internal, notified body, and regulatory audits or inspections as a Quality Engineering subject matter expert
• Coach cross-functional teams in structured problem-solving, statistical methods, validation, and risk-based decision-making
• Report to the Quality Engineering Manager or Quality Operations Manager, as assigned