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. The Senior Associate is responsible for the following activities:

• Own, monitor and troubleshoot analytical bench top equipment.
• Author and own equipment Operating and Maintenance Standard Operating Procedures.
• Act as primary point of contact for QC Equipment group for READ initiatives and projects.
• Support and lead projects to implement new equipment.
• Execute routine maintenance for analytical bench top equipment.
• Establishes and enables LEAN principles.
• Completes all assigned tasks on time, in collaboration with key stakeholders.
• May participate in regulatory inspections.

Basic Qualifications:

Master's Degree

Or

Bachelor's Degree and 2 years of Quality / Operations experience

Or

Associate' Degree and 6 years of Quality / Operations experience

Or

High School Diploma/GED and 8 years of Quality / Operations experience

Preferred Qualifications:

• GMP and GDP experience in a laboratory setting
• Experienced in Quality systems, including deviations and Change Controls
• Experienced in Quality processes, including validation and data integrity
• Proficient in LIMS, Maximo, CDOCS
• Proficient in problem solving and LEAN principles
• Excellent communication skills, including written and verbal
• Experienced in Excel, Power Point, Word, Outlook, Project