Career Category

Job Description

The Sr. Specialist Quality Assurance will be the Subject Matter Expert (SME) for the Deviation and CAPA processes at the Amgen RI facility.  This individual will manage the implementation of process changes, monitor overall health of the Deviation and CAPA processes, liaison with users of the processes to identify opportunities for improvement, and increase proficiency through staff engagement and purposeful presence while supporting the Deviation and CAPA processes.  This individual may provide oversight on complex Quality records (Deviations, CAPAs, Change Controls) as needed.

Responsibilities:

• Purposefully monitors execution of the quality process and communicates performance to GPO/Users & Management​
• Collaborates with functional area leadership to develops clear action plans to address process performance events
• Drives impactful improvement to the process and supporting business processes at the site and network level
• Owns change management related to process and procedure updates.
• Ensures inspection readiness and applicable local procedures are in alignment with quality process requirements and QMS architecture​
• Represents the ARI site at network level to communicate site/functional challenges, lessons learned, audit and inspection findings and best practices​
• Reviews standard, and may author or QA process documentation or training materials​
• On-boards new users; provides training, facilitates learning groups and is a coach/mentor to users​
• Monitors, assesses, and escalates performance issues and trends to the GPO, site management reviews, applicable SMEs and site/functional/regional management​
• Represents process during audits and regulatory agency inspections.​
• Engages with GPO when commitments are made after regulatory inspections ​
• May own or QA (if applicable)  DEV, CAPA/EVs, and change records for process​
• Develops and owns site/region specific commitments for process​
• Alerts senior management of significant quality, compliance, supply and safety risks

Basic Qualifications:

Doctorate degree and 2 years of Quality experience
OR
Master’s degree and 6 years of Quality experience

OR
Bachelor’s degree and 8 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:

• Experience and knowledge of Data Integrity Requirements
• Expertise within the assigned quality process and IS application​
• Knowledge of GxP Regulations and industry standards​
• Strong problem solving, organizational and analytical skills​
• Leadership skills to influence across the sites, functions or regions​
• Strong oral and written communication skills​
• Experience managing change ​
• Ability to navigate through ambiguity
• Experience of collaboration within and across functional areas and outstanding customer service focus