Specialist Supply Chain Compliance

Amgen • Lexington-Fayette, KY

2d

About The Position

Join Amgen’s Mission of Serving Patients At Amgen, if you feel like you’re part of something bigger, it’s because you are. Our shared mission—to serve patients living with serious illnesses—drives all that we do. Since 1980, we’ve helped pioneer the world of biotech in our fight against the world’s toughest diseases. With our focus on four therapeutic areas –Oncology, Inflammation, General Medicine, and Rare Disease– we reach millions of patients each year. As a member of the Amgen team, you’ll help make a lasting impact on the lives of patients as we research, manufacture, and deliver innovative medicines to help people live longer, fuller happier lives. Our award-winning culture is collaborative, innovative, and science based. If you have a passion for challenges and the opportunities that lay within them, you’ll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career. Specialist Supply Chain Compliance What you will do Let’s do this. Let’s change the world. In this vital role you will require a strong ability to collaborate cross-functionally with other Amgen business units.

Requirements

• Doctorate degree OR Master’s degree and 2 years of Supply Chain experience OR Bachelor’s degree and 4 years of Supply Chain experience OR Associate’s degree and 8 years of Supply Chain experience Or High school diploma / GED and 10 years of Supply Chain experience

Nice To Haves

• Experience in audit / inspection support
• Technical writing skills

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.
• Provides 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.
• Supports 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.
• Responsible for hiring, training, supervising, coaching and performance management of SC Compliance staff.

Benefits

• As we work to develop treatments that take care of others, we also work to care for your professional and personal growth and well-being.
• From our competitive benefits to our collaborative culture, we’ll support your journey every step of the way.
• A comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts
• A discretionary annual bonus program, or for field sales representatives, a sales-based incentive plan
• Stock-based long-term incentives
• Award-winning time-off plans
• Flexible work models where possible.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Number of Employees: 5,001-10,000 employees