Manufacturing Specialist

Amgen

. Own, manage, and close quality records, including Supplier Event Notifications and Investigations, Change Controls, Deviations, CAPAs, and CAPA-Effectiveness Verifications .

Posted 11/9/2026full-timeUnited StatesSeniorLead💰 $107,545 - $145,503 per yearWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in managing quality records and ensuring compliance within the pharmaceutical, biotech, or medical device industries. Proficient in leading investigations, utilizing advanced root-cause analysis tools, and collaborating across cross-functional teams to drive continuous improvement and effective quality management.

Highest-signal resume keywords

Quality Record ManagementRoot-Cause AnalysisProject ManagementRegulatory ComplianceCross-Functional Collaboration

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Quality AssuranceChange ControlCAPA ManagementTrackWiseVeeva SystemSAP (ERP)S4HANAAI-Enabled ToolsData Integrity EvaluationTechnical Writing

Soft Skills

Excellent CommunicationInterpersonal SkillsNegotiation SkillsProblem-SolvingFacilitation Skills

Tools & Technologies

Microsoft Office ToolsWordExcelPowerPointProjectTeamsOutlook

Industry Keywords

Pharmaceutical IndustryBiotech IndustryMedical Device IndustryQuality Management SystemSupplier Event NotificationsDeviationsKPI ComplianceContinuous ImprovementManufacturing ExperienceProcess Development

Tech Stack

Tools & technologies

ERP

About the role

Key responsibilities & impact

Own, manage, and close quality records, including Supplier Event Notifications and Investigations, Change Controls, Deviations, CAPAs, and CAPA-Effectiveness Verifications
Ensure compliance with company quality management system procedures and regulatory agency requirements
Facilitate cross-functional teams internally and externally to achieve robust investigations and timely implementation of supplier/raw-material changes
Partner across the network to ensure mature execution of quality record processes
Lead investigation teams to identify root causes and corrective and preventive actions using advanced root-cause analysis tools such as Causal Factor Analysis, Fault Tree Analysis, and Kepner-Tregoe
Manage multiple quality records simultaneously and close them in a timely manner
Collaborate with External Supply Quality, ES SRE teams, Amgen sites, and suppliers on investigations, change implementation, and KPI compliance
Build and present quality record summaries for senior management
Provide process and status updates to senior management and maintain tracking tools
Own and manage quality records originating from manufacturing sites across Amgen’s global network

Requirements

What you’ll need

Doctorate degree OR Master’s degree and 2 years of Quality and/or Manufacturing experience in the pharmaceutical, biotech or medical device industries OR Bachelor’s degree and 4 years of Quality and/or Manufacturing experience in the pharmaceutical, biotech or medical device industries OR Associate’s degree and 8 years of Quality and/or Manufacturing experience in the pharmaceutical, biotech or medical device industries OR High school diploma / GED and 10 years of Quality and/or Manufacturing experience in the pharmaceutical, biotech or medical device industries
3+ years related work experience in manufacturing, process development, or quality assurance in the biotech or pharmaceutical industry
Experience managing quality records using TrackWise or Veeva System
Project management skills and experience
Ability to coordinate and participate in cross-functional project teams and deliver on schedule
Ability to manage multiple priorities in a fast-paced environment with minimal direction
Excellent written and verbal communication skills, including technical writing and presentation skills
Ability to work autonomously, present data logically, meet deadlines, prioritize work, and communicate effectively
Experience presenting to and interacting with regulatory agency representatives
Ability to navigate ambiguity and provide a structured problem-solving approach
Ability to lead continuous improvement opportunities and complex cross-functional initiatives
Proficiency with Microsoft Office Tools: Word, Excel, PowerPoint, Project, Teams, and Outlook
Experience navigating and executing transactions in SAP (ERP) or S4HANA
Experience applying AI-enabled tools in a regulated environment
Experience contributing to the design, development, or implementation of AI-enabled tools
Ability to translate business or quality process needs into practical solutions and evaluate outputs for accuracy, data integrity, and compliance
Interpersonal and facilitation skills to forge consensus among challenging client interests
Ability to tactfully negotiate and positively influence peers and executive leadership
Strong negotiation skills with external suppliers and internal team members
Ability to maintain remote working relationships with colleagues at other Amgen sites
Sponsorship for this role is not guaranteed

Benefits

Comp & perks

A comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions
Group medical, dental and vision coverage
Life and disability insurance
Flexible spending accounts
Discretionary annual bonus program
Stock-based long-term incentives
Award-winning time-off plans
Flexible work models where possible
Career development opportunities
Financial plans with opportunities to save towards retirement or other goals
Work/life balance support