Sr Associate Supply Chain Compliance

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.

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.

Specific responsibilities include but are not limited to:

• →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.

We are all different! Yet, we all use our unique contributions to serve patients. The Associate Tech Engineering professional we seek is an individual contributor with these qualifications.

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

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.

In addition to the base salary, Amgen offers a Total Rewards Plan, based on eligibility, comprising of health and welfare plans for staff and eligible dependents, financial plans with opportunities to save towards retirement or other goals, work/life balance, and career development opportunities that may include:

• 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. Refer to the Work Location Type in the job posting to see if this applies.

In any materials you submit, you may redact or remove age-identifying information such as age, date of birth, or dates of school attendance or graduation. You will not be penalized for redacting or removing this information.

Sponsorship for this role is not guaranteed.

As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other and live the Amgen values to continue advancing science to serve patients. Together, we compete in the fight against serious disease.

Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or any other basis protected by applicable law.

We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.