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

• Provide overall quality support for customers, manufacturing, and engineering.
• Increase customer satisfaction, decrease warranty and scrap cost, and improve overall product quality.
• Interact with other departments to efficiently meet customer needs.
• Support production by utilizing Lean Principles to develop and improve processes that meet quality standards and customer demands.
• Lead continuous improvement initiatives using Lean Six Sigma methodologies to enhance safety, quality, productivity, and operational performance.
• Develop, implement, and sustain manufacturing processes, standard work, training programs, engineering changes, and process controls.
• Drive root cause analysis, corrective and preventive actions, capability studies, and process compliance.
• Collaborate across cross-functional teams to solve complex manufacturing challenges, support production operations, and achieve plant and company objectives.

• Ensure the quality of IT Validation & Compliance infrastructure in a Contract Development and Manufacturing Organization (CDMO) setting
• Review and approve enterprise software validation lifecycle deliverables
• Provide global oversight of enterprise software validation
• Review and approve enterprise software change controls, CAPAs, and deviations
• Support the global data integrity initiative
• Provide strategic and technical expertise on global software validation matters
• Ensure compliance with cGMPs, legal and regulatory requirements, and KBI internal requirements

Principal Specialist – Quality Validation

• Review proposals, contracts, regulatory, program, and customer requirements for early quality involvement
• Prepare and maintain Quality directives, policies, processes, procedures, and metrics
• Analyze process data, metrics, models, and flows to identify root causes
• Develop preventive or corrective actions with stakeholders
• Research, compile, and analyze performance reports and process-control statistics
• Conduct supplier quality source selection and process reviews
• Conduct hardware, software, and system-level audits
• Analyze data to provide material review dispositions for nonconforming materials, parts, and equipment
• Work under general direction

Quality Production Specialist, General

• Review proposals, contracts, regulatory, program, and customer requirements to ensure early quality involvement in program development
• Prepare and maintain Quality directives, policies, processes, procedures, and metrics
• Analyze process data, metrics, models, and flows to identify root causes
• Develop preventive or corrective actions with stakeholders and support implementation
• Research, compile, and analyze performance reports and process control statistics
• Conduct quality source selection and supplier process reviews
• Conduct hardware, software, and system-level audits
• Report audit results to management
• Analyze data to provide material review dispositions for nonconforming materials, parts, and equipment
• Work under general direction

Quality Production Specialist – General

• Review proposals, contracts, regulatory, program, and customer requirements for early quality involvement
• Prepare and maintain Quality directives, policies, processes, procedures, and metrics
• Analyze process data, metrics, models, and flows to identify root causes
• Develop preventive or corrective actions with stakeholders and support implementation
• Research, compile, and analyze performance reports and process control statistics
• Conduct quality source selection and supplier process reviews
• Conduct hardware, software, and system-level audits and report results to management
• Analyze data to provide material review dispositions for nonconforming materials, parts, and equipment
• Work under general direction

• Support certification compliance initiatives across brands, products, manufacturing/packaging sites, and business transitions
• Review products, labels, formulations, ingredients, and related documentation against certification requirements
• Identify compliance gaps and coordinate corrective actions
• Partner with internal teams, suppliers, contract manufacturers, and certifying agencies on applications, renewals, audits, and compliance milestones
• Maintain certification records, trackers, approvals, and documentation
• Monitor timelines, communicate status, and escalate compliance risks
• Manage retailer testing activities, including requirement review, SKU tracking, submissions, sample coordination, and follow-up
• Prepare and submit product documentation, specifications, certificates, test reports, and supporting materials to retailers and laboratories
• Review testing results and escalate potential compliance gaps or out-of-specification findings
• Maintain testing records, retailer portal data, approvals, and due dates
• Analyze trends, support audit readiness, and drive continuous improvement

Quality Specialist – Certifications, Retail Testing

• Review proposals, contracts, regulatory, program, and customer requirements to ensure early quality involvement in program development
• Prepare and maintain Quality directives, policies, processes, procedures, and metrics
• Ensure program, contract, customer, regulatory, international standards, and working agreement requirements are deployed
• Analyze process data, metrics, models, and flows to identify root causes
• Work with stakeholders to develop preventive and corrective actions and support implementation
• Conduct research and analyze performance reports and process control statistics to improve process capability
• Conduct supplier quality source selection and process reviews
• Develop coordinated responses for management review and approval
• Conduct hardware, software, and system-level audits for compliance with quality management system standards and other requirements
• Report audit results to management
• Analyze data to provide material review dispositions for nonconforming materials, parts, and equipment
• Work under general direction

• Review proposals, contracts, regulatory, program, and customer requirements for early quality involvement
• Prepare and maintain Quality directives, policies, processes, procedures, and metrics
• Analyze process data, metrics, models, and flows to identify root causes
• Develop preventive or corrective actions with stakeholders
• Research, compile, and analyze performance reports and process control statistics
• Conduct supplier quality source selection and process reviews
• Conduct hardware, software, and system-level audits
• Analyze data to provide material review dispositions for nonconforming materials, parts, and equipment
• Work under general direction

• Review proposals, contracts, regulatory, program, and customer requirements for early quality involvement
• Prepare and maintain Quality directives, policies, processes, procedures, and metrics
• Deploy program, contract, customer, regulatory, international standards, and working agreement requirements
• Analyze process data, metrics, models, and flows to identify root causes
• Develop preventive or corrective actions with stakeholders and support implementation
• Research, compile, and analyze performance reports and process control statistics
• Continuously improve process capability
• Conduct supplier quality source selection and process reviews
• Develop coordinated responses for management review and approval
• Conduct hardware, software, and system-level audits
• Report audit results to management
• Analyze data to provide material review dispositions for nonconforming materials, parts, and equipment
• Work under general direction