Career Category

Job Description

Responsible for proving quality oversight functions related to the manufacture of Bulk Drug Substance at Amgen Rhode Island.

Responsibilities:

• Leading and project managing complex investigations for major and critical deviation events associated with Amgen’s manufactured products, raw materials, Quality Control systems and processes, including manufacturing investigations.
• Providing Quality oversight of Minor Deviations, CAPA and EV records.
• Providing Quality oversight on the day to day supply and management of raw materials, packaging and components.
• Leading and project managing Change Control records for analytical method revisions, equipment installation and validation.
• Responsible for Quality and/or Validation Assessor for Change Controls.
• Supporting QC Equipment Life Cycle Management Program.
• Providing Quality oversight of supporting QC and Contract Testing Laboratory (CTL) testing readiness activities.
• 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 experience
• OR
• Bachelor’s degree and 5 years of Quality experience
• OR
• Associate’s degree and 10 years of Quality experience
• OR
• High school diploma / GED and 12 years of Quality experience

Preferred Qualifications:

• Previous experience in Quality Systems (Investigations, CAPAs, EVs, Change Controls)
• Validation experience (Lab equipment, computer related systems)
• Project management
• Proficiency in Excel, Word, and Power Point
• 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