Sr Associate Supply Chain Compliance

1001 Amgen Inc.; Louisville (KY); Presencial; USD 81.000 - 110.000; Tempo integral

Resumo da vaga

Amgen seeks a Sr Associate Supply Chain Compliance to join its Louisville, KY operations. The role emphasizes ownership of temperature records, deviation management, CAPA, and event reviews, with emphasis on inspection readiness across US and LACAN supply chains.

Responsibilities include maintaining daily management sheets, supporting recalls or mock recalls, and driving continuous improvement using a risk-based approach.

Qualificações

• 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).
• Experience in deviation management and 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.

Responsabilidades

• 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 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.

Conhecimentos

Quality Assurance

GMP/GDP

English fluency

Technical writing

Word processing

Databases

Spreadsheets

QMS systems

Audit support

Deviation management

Risk-based decisions

Analytical thinking

Cross-cultural comms

Formação

Master’s degree

Bachelor’s degree + 2 years GMP/GDP

Associate’s degree + 6 years GMP/GDP

High school diploma/GED + 8 years GMP/GDP

Ferramentas

Veeva

SAP

Descrição da vaga

Career Category Operations Job Description

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.

• 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.

What we expect of you

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.

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

What you can expect of us

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.

Sponsorship

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.

Application deadline

Amgen does not have an application deadline for this position; we will continue accepting applications until we receive a sufficient number or select a candidate for the position.

Amgen is an Equal Opportunity employer

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.

Salary Range

81.328,85USD -110.033,15 USD

Amgen is committed to unlocking the potential of biology for patients suffering from serious illnesses by discovering, developing, manufacturing and delivering innovative human therapeutics. This approach begins by using tools like advanced human genetics to unravel the complexities of disease and understand the fundamentals of human biology. Amgen focuses on areas of high unmet medical need and leverages its biologics manufacturing expertise to strive for solutions that improve health outcomes and dramatically improve people's lives. A biotechnology pioneer since 1980, Amgen has grown to be one of the world's leading independent biotechnology companies, has reached millions of patients around the world and is developing a pipeline of medicines with breakaway potential.

For more information, visit www.amgen.com and follow us on www.twitter.com/amgen