Specialist Supply Chain Compliance
Amgen
Remote friendly (Louisville, KY)
United States
Operations
Role Summary
Specialist Supply Chain Compliance responsible for managing deviations, CAPA, temperature excursions, distribution complaints, and quality system monitoring. Collaborates cross-functionally with other Amgen business units, supports inspection readiness, and drives process improvements to ensure compliance with GDP and FMD guidelines.
Responsibilities
- Own and manage deviations, trend investigations records, CAPA and CAPA EV records. Lead root cause analysis sessions.
- Own and manage the trend trigger and periodic evaluation report for temperature excursions and distribution complaints.
- Provide training sessions related to SC Compliance.
- Act as Subject Matter Expert (SME) for the Quality Systems Deviation, CAPA, CAPA EV, Temperature excursion, Distribution Complaint and Periodic monitoring.
- Participate in and support inspection readiness activities, audits and inspections.
- Deploy new (global) capabilities and projects as appropriate.
- Support change management and operational excellence initiatives to improve process compliance performance.
- Author and own documents (procedures, forms, manuals, training materials etc.) for the SC Compliance team.
- Lead Event Review meetings for missing product events.
- Perform data analysis for Management reviews of the quality system on a periodic basis.
- Incidentally own and manage temperature excursion records of products.
- Provide guidance/direction in all areas of GDP and FMD.
Management Responsibilities
- Responsible for hiring, training, supervising, coaching and performance management of SC Compliance staff.
Qualifications
- Required: Doctorate degree
- Required: Master’s degree and 2 years of Supply Chain experience
- Required: Bachelor’s degree and 4 years of Supply Chain experience
- Required: Associate’s degree and 8 years of Supply Chain experience
- Required: High school diploma / GED and 10 years of Supply Chain experience
- Preferred: Experience in audit / inspection support
- Preferred: Technical writing skills
Education
- Doctorate degree
- Master’s degree
- Bachelor’s degree
- Associate’s degree
- High school diploma / GED