Career Category

Job Description

The Amgen Rhode Island Quality Control Equipment group is responsible for the entire end to end life cycle of equipment at QC. This includes procurement, development and execution of validation and change control strategy, oversight of general and preventive maintenance activities, and decommission support as required.

Responsibilities:

• Manage the life cycle for Quality Control (QC) equipment, as system owner. Interact routinely with end customers and vendors, ensuring reliable QC equipment support in a fast-paced environment.
• Manage the procurement of new QC equipment. Work autonomously to lead cross-functional stakeholders to identify end-user requirements, establish validation requirements and Change Control strategy.
• Lead departmental capital funding projects. Lead and support Governance requirements to secure funding. Responsible to implement projects on time and on budget.
• Responsible for Quality and/or Validation Assessments for Change Controls.
• Supports inspection readiness activities across Quality Control, and site audits and inspections.

Basic Qualifications

Doctorate degree

OR

Master’s degree and 3 years of Quality or Operations experience

OR

Bachelor’s degree and 5 years of Quality or Operations experience

OR

Associate’s degree and 10 years of Quality or Operations experience

OR

High school diploma / GED and 12 years of Quality or Operations experience

Preferred Qualifications

• Previous experience in Quality Systems (Deviations, Corrective Actions/Preventative Actions, and/or Change Controls)
• Validation experience (Lab equipment, computer related systems)
• Project management
• Proficiency in Excel, Word, and PowerPoint
• Strong interpersonal skills
• Excellent written and verbal communication skills (including technical writing and presentations) with ability to communicate and collaborate effectively with technical and senior management staff