Amgen

Amgen

External Supply RMD QRO Specialist

US - Ohio - Columbus

Sponsorship not specifiedDetected 67 days ago
Site Reliability EngineeringProject ManagementNegotiationExcelSAPERPMedical DevicesResearchCommunicationProblem SolvingCritical ThinkingPublic SpeakingWritingMicrosoft Office

Stay score

odds of building a lasting career here

38Risky
Cap-exempt (no lottery)0
Sponsors this role85
Entry-level history0
PERM / green-card track0
Lottery odds40
Fits your clock70

Thin sponsorship signal and lottery-bound. A low-probability bet with your clock running. Prioritize cap-exempt roles and proven entry-level sponsors first.

Lottery odds assume a STEM candidate.

Personalize to your clock →

Employer immigration record

from this employer's Department of Labor filings

Green-card filing pattern in this occupation

Context, not a finding about this posting: of this employer's 101 green-card filings in this occupation, 100% were for a worker who already held the job.

Green-card follow-through: 92%

Of 75 labor certifications old enough to have been used, 6 expired without the employer filing the next step. Median time from filing to decision: 486 days.100% of their filings were for a worker who already held the job.Only certifications past the 180-day window are counted — recent ones cannot have expired yet.

Files H-1B transfers

17 transfer filings in the last year, covering 17 workers. Median labor-condition decision: 7 days. An employer that already files transfers is one that can take over an existing H-1B.

Sourced from Department of Labor LCA, PERM and prevailing-wage disclosure data. Employer matching is by name, so figures may be split across an employer's legal entities. Absence of a filing means none appears in our copy of the data, not that none exists.

Community outcomes

No reports yet — be the first to help the next applicant.

About the role

  • Join Amgen's Mission of Serving Patients
  • At Amgen, if you feel like you're part of something bigger, it's because you are.
  • Since 1980, we've helped pioneer the world of biotech in our fight against the world's toughest diseases.

Responsibilities

  • 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.
  • The External Supply QRO Specialist 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.
  • 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.

Requirements

  • Doctorate degree
  • Demonstrated proficiency in managing change controls in alignment with quality system requirements, regulatory expectations, and business timelines

Nice to have

  • Experience in devices and primary and secondary packaging materials
  • Experience managing quality records (EN/SICAR, Change Controls, Deviations, CAPAs, CAPA-EV) using TrackWise or Veeva System
  • Project Management and/or Quality Management skills and experience.
  • Experience in leading multiple, contending priorities in a fast-paced environment with minimal direction.
  • 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.
  • Proficient with Microsoft Office Tools (Word

Compensation

  • 107,545.40USD -145,502.60 USD

Company info

  • Career Category Manufacturing Job Description Join Amgen's Mission of Serving Patients At Amgen, if you feel like you're part of something bigger, it's because you are.
  • If you have a passion for challenges and the opportunities that lay within them, you'll thrive as part of the Amgen team.
  • What we expect of you We are all different, yet we all use our unique contributions to serve patients.

Equal opportunity

  • Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or any other basis protected by applicable law.
  • Please contact us to request accommodation.
  • Equal Opportunity employer and will consider you without regard to your race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status.
  • We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment.

Visa & Work Authorization

  • Sponsorship for this role is not guaranteed.
Apply directly at Amgen →Create a free account for alerts like thisView Amgen immigration profile

This listing is sourced directly from Amgen's careers page and normalized into a canonical job model.