Senior Associate Quality Systems - Warehouse

Amgen • Holly Springs, NC

254d • Hybrid

About The Position

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.

Requirements

• High school diploma/GED and 4 years of operations, business, or supply chain experience OR Associates Degree and 2 years of operations, business, or supply chain experience OR Bachelor's degree and 6 months of operations, business, or supply chain experience OR Master's degree.

Nice To Haves

• Technical Writing skills - Preferred experience writing and owning deviation records and procedures.
• Experience conducting Investigations and root cause analysis.
• Process Improvement with a Continuous improvement mentality.
• Experience supporting Compliance inspections in GMP environments.
• Supply Chain & Logistics Management, Science or Engineering educational background.
• Supply Chain experience with a focus on warehouse operations and systems.
• Knowledge of Supply Chain processes, and Operational Excellence.
• Basic knowledge of ERP (SAP) and SAP Warehouse Management (WM).
• Good understanding of Warehouse Master Data in SAP.
• Good understanding of current Good Manufacturing/Distribution Practices.
• Quick process understanding, insight and visualizing.
• Experience in managing projects or work streams (cross functional).
• Availability to support non-standard shift organization with the flexibility to work extended hours.
• Good organizational and negotiation skills.
• Experience working in a global environment, ability to collaborate closely/communicate effectively at different management levels.
• Proficient user of software applications (Excel, PowerPoint, Smartsheet, Skype, Tableau).

Responsibilities

• Participate in multiple cross-functional initiatives for Amgen North Carolina (ANC) warehouse.
• Serve as warehouse Subject Matter Expert and as site representative on various cross-functional task forces and teams.
• Own and manage warehouse quality systems records, including deviations, change control records, CAPA records, documentation and training.
• Support operational readiness and inspection readiness activities.
• Lead triage meetings.
• Track and manage timely closure of quality records.
• Timely escalate issues to prevent impact to timelines.
• Become an SME on quality systems related to the warehouse.
• Represent ANC Supply Chain in interdisciplinary system-related projects/initiatives and possibly lead work streams within such projects.
• Identify and manage warehouse risks.
• Lead inspection readiness initiatives for the warehouse.
• Own relevant Supply Chain procedures and conduct required periodic reviews.
• Establish relationships with key stakeholders across multiple functional areas, both onsite and virtually.

Benefits

• 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.
• 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, including remote and hybrid work arrangements, where possible.

What This Job Offers

• Job Type: Full-time
• Career Level: Entry Level
• Industry: Chemical Manufacturing
• Education Level: Bachelor's degree