Career CategoryManufacturing
Job DescriptionSpecialist Manufacturing - External Supply, Raw Materials and Devices Quality RecordsWhat you will doLet's do this. Let's change the world. The External Supply (ES) Raw Material and Devices Quality Records (RMD QRO) global team plays a vital role in supporting the Amgen manufacturing network. Our work includes managing supplier notifications and investigations related to raw material and device defects, onboarding new or alternate raw materials, suppliers, sites, and managing life-cycle changes to existing materials or suppliers. The External Supply Specialist Manufacturing is expected to own and execute independently all the processes related to Raw Material and Devices (RMD) quality records, including Supplier Event Notifications and Investigations (EN/SICAR), Change Controls, Deviations (minor and major), Corrective and Preventive Actions (CAPAs), CAPA-Effectiveness Verifications. This Specialist Manufacturing will act as the External Supply QRO representative across functional teams and external suppliers to drive closure of quality records in a timely manner. The Specialist Manufacturing External Supply owns and manages quality records originating from manufacturing sites across the global Amgen network.
Responsibilities:Responsibilities include, but are not limited to the following:
- Own, manage, and close quality records (Supplier Event Notifications and Investigations (EN/SICAR), Change Controls, Deviations, Corrective and Preventive Actions (CAPAs), and CAPA-Effectiveness Verifications) under the company's quality management system procedures and ensure compliance with regulatory agency requirements.
- Facilitation of cross-functional teams (internal and external to the site) with the goal of achieving robust and detailed investigation performance or timely implementation of supplier/raw material related changes.
- Partner cross-functionally across the network to ensure maturity and execution of robust quality record process.
- Lead investigation teams to identify meaningful root causes and robust corrective and preventative actions by effectively utilizing advanced root cause analysis tools (Causal Factor Analysis, Fault Tree Analysis, Kepner-Tregoe, etc.)
- Manages closure of multiple quality records simultaneously and in a timely matter (Deviations, Change Controls, ENs, SICARs, CAPA, CAPA-EV).
- Collaborate closely with External Supply Quality, ES SRE teams, Amgen sites, and suppliers to ensure robust supplier/raw material investigations, timely change implementation, and compliance with KPI metrics.
- Build and present quality record summaries for Senior Management review. Provide timely and comprehensive process and status updates to senior management in multiple forums and keeping tracking tools updated.
What we expect of youWe are all different, yet we all use our unique contributions to serve patients. The professional we seek is a highly organized and collaborative individual with strong project coordination, communication, and problem-solving skills.
Basic Qualifications:- Doctorate degree OR
- Master's degree and 2 years of experience in Quality and/or Manufacturing in the pharmaceutical, biotech or medical device industries OR
- Bachelor's degree and 4 years of experience in Quality and/or Manufacturing in the pharmaceutical, biotech or medical device industries OR
- Associate's degree and 8 years of experience in Quality and/or Manufacturing in the pharmaceutical, biotech or medical device industries OR
- High school diploma / GED and 10 years of experience in Quality and/or Manufacturing in the pharmaceutical, biotech or medical device industries.
Preferred Qualifications:- 3+ years related work experience (manufacturing, process development, or quality assurance) in Biotech or pharmaceutical industry with progressively increasing responsibility and demonstrated experience in compliance, problem solving, critical thinking, project management, and quality systems.
- Experience managing quality records (EN/SICAR, Change Controls, Deviations, CAPAs, CAPA-EV) using TrackWise or Veeva System
- Demonstrated proficiency in managing change controls in alignment with quality system requirements, regulatory expectations, and business timelines
- Project Management and/or Quality Management skills and experience. Demonstrated ability to coordinate and effectively participate in cross-functional project teams and deliver on schedule.
- Experience in leading multiple, contending priorities in a fast-paced environment with minimal direction.
- Excellent communication skills, both written and verbal (including technical writing and presentation skills) with ability to collaborate productively with technical and senior management staff.
- Demonstrated ability to work autonomously, present data in an organized and logical manner, meet deadlines, prioritize work and communicate effectively.
- Experience presenting to and interacting with representatives of regulatory agencies.
- Demonstrated ability to navigate through ambiguity and provide a structured problem-solving approach.
- Demonstrated ability to lead continuous improvement opportunities and complex cross-functional initiatives that enhance processes, improve operational efficiency, and support timely, compliant execution across internal teams and Amgen sites.
- Proficient with Microsoft Office Tools (Word; Excel; PowerPoint; Project, Teams, Outlook)
- Experience navigating and executing transactions in SAP (ERP) or S4HANA system.
- Interpersonal and facilitation skills necessary to forge consensus among challenging client interests while ensuring objectives are met.
- Ability to tactfully negotiate and positively influence peers and executive leadership.
- Demonstrated ability to deliver results through living the Amgen values.
- Strong negotiation skills when working with external suppliers and internal team members.
- Ability to maintain remote working relationships with colleagues at other Amgen sites.
What you can expect from usAs we work to develop treatments that take care of others, we also work to care for your professional and personal growth and well-being. From our competitive benefits to our collaborative culture, we'll support your journey every step of the way.
The expected annual salary range for this role in the U.S. (excluding Puerto Rico) is posted. Actual salary will vary based on several factors including but not limited to, relevant skills, experience, and qualifications.
In addition to the base salary, Amgen offers a Total Rewards Plan, based on eligibility, comprising of health and welfare plans for staff and eligible dependents, financial plans with opportunities to save towards retirement or other goals, work/life balance, and career development opportunities that may include:
- 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, and flexible spending accounts
- A discretionary annual bonus program, or for field sales representatives, a sales-based incentive plan
- Stock-based long-term incentives
- Award-winning time-off plans
- Flexible work models where possible. Refer to the Work Location Type in the job posting to see if this applies.
Apply now and make a lasting impact with the Amgen team.
careers.amgen.comSalary Range107,545.40USD -145,502.60 USD
