Sr Associate Supply Chain Compliance

Amgen • Juncos, PR

7d

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. Sr Associate Supply Chain Compliance What you will do Let’s do this. Let’s change the world. In this vital role you will serve as a key compliance partner within the US and LACAN Supply Chain, safeguarding product quality and patient trust through the effective implementation of GDP requirements, quality systems, and regulatory standards. Lead critical quality processes, identify and mitigate risks, and drive operational excellence across the distribution network.

Requirements

• Master’s degree in Life Sciences OR Bachelor’s degree in Life Sciences and 2 years of GMP / GDP compliance experience OR Associate’s degree in Life Sciences and 6 years of GMP / GDP compliance experience OR High school diploma / GED and 8 years of GMP / GDP compliance experience
• Sound knowledge of Quality Assurance principles, Good Manufacturing Practice, and Good Distribution Practice
• Fluency in English
• Technical writing skills
• Strong word processing, database, and spreadsheet application skills and experience in Quality Management Software systems (e.g., Veeva, SAP, etc.)
• Experience in deviation management and audit/inspection support
• Experience in audit / inspection support
• Effective communication skills at multiple levels, areas, and countries
• Ability to apply a risk-based approach, making decisions and escalating issues appropriately
• Analytical and evidence-based approach to problems
• Ability to see the connection between issues, identify common factors, and bring the correct stakeholders together

Responsibilities

• Own and manage temperature assessment records.
• Own and manage minor and major deviation records and lead root cause analysis sessions.
• Own and manage CAPA and CAPA EV records, ensuring that they are implemented as intended.
• Manage missing product notifications, including leading Event Review Team meetings if applicable.
• Support inspection readiness activities and support audits and inspections involving the US and LACAN supply chain.
• Manage and own Periodic Evaluation reports.
• Support activities for product recall or annual mock recall exercises.
• Ensure up-to-date daily management sheets for minor, major, temperature excursions, and missing product events.
• Support continuous improvement activities.
• Ensure up-to-date spreadsheets for minor, major, temperature excursions, and missing products.

Benefits

• A comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental & vision coverage, and life & disability insurance
• 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: Entry Level