Specialist Manufacturing

Amgen•Thousand Oaks, CA

1d•$107,545 - $145,503

About The Position

The Specialist Manufacturing works on Amgen’s External Supply Raw Material and Devices Quality Records global team, supporting the manufacturing network. The role independently owns and executes quality-record processes for raw materials and devices, including supplier event notifications and investigations, change controls, deviations, CAPAs, and CAPA-effectiveness verifications. The specialist represents External Supply QRO across functional teams and external suppliers, managing records originating from manufacturing sites across the global Amgen network and driving their timely closure in compliance with company procedures and regulatory requirements. The role leads and facilitates internal and external cross-functional teams to investigate supplier or raw-material issues, identify root causes, and implement corrective actions or changes. It also involves managing multiple records concurrently, collaborating with External Supply Quality, ES SRE teams, Amgen sites, and suppliers, and preparing quality-record summaries and status updates for senior management.

Requirements

Doctorate degree; or a master’s degree and 2 years of Quality and/or Manufacturing experience in the pharmaceutical, biotech, or medical device industries; or a bachelor’s degree and 4 years of such experience; or an associate’s degree and 8 years of such experience; or a high school diploma/GED and 10 years of such experience.
Ability to work autonomously, organize and present data, meet deadlines, prioritize work, and communicate effectively.
Strong written and verbal communication skills, including technical writing and presentations, and ability to collaborate with technical staff and senior management.
Interpersonal and facilitation skills to build consensus among competing interests while achieving objectives.
Ability to tactfully negotiate and positively influence peers and executive leadership.
Strong negotiation skills when working with external suppliers and internal team members.
Ability to maintain remote working relationships with colleagues at other Amgen sites.
Demonstrated ability to deliver results in alignment with Amgen values.

Nice To Haves

At least 3 years of related work experience in manufacturing, process development, or quality assurance in the biotech or pharmaceutical industry, with increasing responsibility and demonstrated compliance, problem-solving, critical-thinking, project-management, and quality-systems experience.
Experience managing quality records (EN/SICAR, change controls, deviations, CAPAs, CAPA-EV) using TrackWise or Veeva.
Project-management experience and demonstrated ability to coordinate and contribute to cross-functional teams and deliver on schedule.
Experience managing multiple competing priorities in a fast-paced environment with minimal direction.
Experience presenting to and interacting with regulatory-agency representatives.
Ability to navigate ambiguity and apply a structured problem-solving approach.
Experience leading continuous-improvement opportunities and complex cross-functional initiatives to improve processes and operational efficiency and support timely, compliant execution.
Proficiency with Microsoft Office tools, including Word, Excel, PowerPoint, Project, Teams, and Outlook.
Experience navigating and executing transactions in SAP ERP or S/4HANA.
Experience applying AI-enabled tools in a regulated environment.
Experience contributing to the design, development, or implementation of AI-enabled tools for process-improvement initiatives or projects; ability to translate business or quality-process needs into practical solutions and assess outputs for accuracy, data integrity, and compliance.

Responsibilities

Own, manage, and close supplier event notifications and investigations (EN/SICAR), change controls, deviations, CAPAs, and CAPA-effectiveness verifications under company quality-management procedures and regulatory requirements.
Facilitate internal and external cross-functional teams to support thorough investigations and timely implementation of supplier- or raw-material-related changes.
Partner across the network to support effective execution of the quality-record process.
Lead investigation teams in identifying root causes and corrective and preventive actions, using tools such as Causal Factor Analysis, Fault Tree Analysis, and Kepner-Tregoe.
Manage the timely closure of multiple quality records simultaneously, including deviations, change controls, ENs, SICARs, CAPAs, and CAPA-EVs.
Collaborate with External Supply Quality, ES SRE teams, Amgen sites, and suppliers on investigations, change implementation, and KPI compliance.
Prepare and present quality-record summaries for senior management, provide process and status updates in management forums, and keep tracking tools current.