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Senior Associate Quality Systems - Warehouse

Career Category

Supply Chain

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 Warehouse Quality Systems

What you will do

Let’s do this! Let’s change the world!

In this vital role you will be part of the Supply Chain team, and you will participate in multiple cross-functional initiatives for Amgen North Carolina (ANC) warehouse. You will serve as warehouse Subject Matter Expert and as site representative on various cross-functional task forces and teams to ensure that consistent and well-integrated practices are developed throughout the organization. The focus of the Sr. Associate is to own and manage warehouse quality systems records, including deviations, change control records, CAPA records, documentation and training, as well as supporting operational readiness and inspection readiness activities.

  • Lead triage meetings

  • Own quality systems records, such as deviations, change control records and CAPA records.

  • 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 (e.g., investigations and CAPA agreements)

  • 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.

What we expect of you

We are all different, yet we all use our unique contributions to serve patients. The dynamic professional we seek is a strong strategic problem solver with these qualifications.

Basic Qualifications:

  • 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

Preferred Qualifications:

  • 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).

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.

The expected annual salary range for this role in the U.S. (excluding Puerto Rico) is posted. Actual salary will vary based on several factors including but not limited to, relevant skills, experience, and qualifications.

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 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, including remote and hybrid work arrangements, where possible

Apply now

for a career that defies imagination

Objects in your future are closer than they appear. Join us.

careers.amgen.com

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.

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.

.

Salary Range

87,257.00 USD - 106,855.00 USD
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Average salary estimate

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$87257K
$106855K

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What You Should Know About Senior Associate Quality Systems - Warehouse, Amgen

At Amgen, we believe in making a difference in the lives of patients living with serious illnesses, and we're looking for a dedicated Senior Associate Quality Systems for our Holly Springs, North Carolina warehouse to be part of this mission. As a vital member of the Supply Chain team, you'll take on a key role in managing warehouse quality systems records like deviations and CAPA records, ensuring that our operations meet the highest standards. You'll lead triage meetings, track quality records, and be a subject matter expert regarding warehouse compliance and best practices. Your collaboration skills will shine as you work cross-functionally on projects that enhance operational and inspection readiness. We’re looking for someone proactive who can identify warehouse risks and maintain relationships with stakeholders across various levels of the organization. This role requires you to be hands-on in supporting compliance inspections in GMP environments and to have a continuous improvement mentality for process enhancements. Whether you come from a technical background or have experience in supply chain logistics, your unique contributions will help shape our quality systems and improve the lives of patients worldwide with innovative solutions. If you thrive in a dynamic environment and love the challenge of solving problems, consider joining Amgen's dedicated team, where we work together toward transformative health care solutions.

Frequently Asked Questions (FAQs) for Senior Associate Quality Systems - Warehouse Role at Amgen
What are the responsibilities of a Senior Associate Quality Systems at Amgen?

As a Senior Associate Quality Systems at Amgen, you will manage critical warehouse quality systems records, lead triage meetings, and track the timely closure of quality records. You’ll also act as a SME for warehouse-related quality systems, represent the Supply Chain in interdisciplinary projects, identify risks, and support inspection readiness. Additionally, maintaining strong relationships with stakeholders and overseeing relevant procedures are key functions of this role.

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What qualifications do I need to apply for the Senior Associate Quality Systems position at Amgen?

To apply for the Senior Associate Quality Systems position at Amgen, you should have a high school diploma/GED combined with 4 years of relevant operations or supply chain experience, or equivalent qualifications like an Associate’s or Bachelor’s degree with appropriate experience levels. Preferred qualifications include technical writing skills, knowledge of supply chain processes and GMP practices, and experience with investigations and compliance inspections.

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How does collaboration play a role in the Senior Associate Quality Systems job at Amgen?

Collaboration is crucial in the Senior Associate Quality Systems role at Amgen, as you will be engaging with multiple cross-functional teams. You will represent the warehouse in system-related projects, work closely with stakeholders to ensure compliance, and facilitate initiatives that improve operational and inspection readiness. Effective communication and teamwork will help drive the success of quality systems in the warehouse.

Join Rise to see the full answer
What types of software systems should a Senior Associate Quality Systems at Amgen be familiar with?

A Senior Associate Quality Systems at Amgen should have a good understanding of software applications such as ERP systems (like SAP), data management tools, and proficiency in applications like Excel, PowerPoint, and Tableau. Knowledge in SAP Warehouse Management and mastering the data associated with it will be beneficial for managing warehouse quality processes effectively.

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What opportunities for professional growth are available for Senior Associates at Amgen?

Amgen provides numerous opportunities for professional growth for Senior Associates, including career development programs, flexible working models, and access to a comprehensive benefits package. As part of a culture that encourages innovation and teamwork, you’ll be supported in pursuing your career goals while making a meaningful impact in the biotech field.

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Common Interview Questions for Senior Associate Quality Systems - Warehouse
Can you describe your experience with quality systems in a warehouse environment?

When answering this question, focus on specific examples of your experience managing quality records, documenting deviations, and ensuring compliance with GMP regulations. Highlight your role in cross-functional projects and your approach to problem-solving in a fast-paced environment.

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How do you prioritize tasks when managing multiple quality records?

It's essential to demonstrate your organizational skills. Discuss your method for categorizing tasks based on urgency and impact, and how you communicate with your team to ensure timely closure of quality records, preventing any potential operational delays.

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What strategies do you employ to ensure inspection readiness?

Explain your proactive approach to inspection readiness, including routine audits and checks of quality systems, continuous training of staff on compliance, and effective record-keeping that would make the inspection process seamless and successful.

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How do you handle conflicts or disagreements with team members regarding quality processes?

Illustrate your conflict resolution techniques by providing examples of how you have navigated disagreements. Emphasize the importance of open communication, seeking a collaborative solution, and maintaining a focus on the ultimate goal of patient safety and compliance.

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What do you consider the most crucial aspect of a quality system in the warehouse?

Identify what you believe are the key elements, such as documentation accuracy, training of personnel, and consistent process reviews. Justify your choice with your experience or data-backed insights on how these factors affect overall operational efficiency.

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Can you provide an example of a time when you implemented a process improvement?

Share a specific instance where you identified a gap in the quality system and executed a solution. Discuss the problem, your approach to improvement, and the measurable results that followed to show your impact on operational excellence.

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What experience do you have in conducting investigations and root cause analysis?

Detail your experience with incident investigations, emphasizing how you apply analytical and problem-solving skills to identify root causes. Talk about the methodologies you use and any significant outcomes that resulted from your investigations.

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How do you stay updated with changes in regulations and best practices in quality management?

Discuss your commitment to continuous learning by explaining how you stay informed about industry developments. This might include attending webinars, professional conferences, and engaging with relevant literature or regulatory agencies to enhance your profession.

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What role do you think technology plays in improving quality systems?

Articulate your understanding of how technology can streamline quality management processes, such as using data analytics for trend analysis and improving documentation through digital tools. Share examples of technology you've used to enhance productivity or compliance.

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Why do you want to work at Amgen as a Senior Associate Quality Systems?

Craft a compelling answer that reflects your alignment with Amgen's mission of serving patients, as well as your enthusiasm for quality systems. Mention how your skills match the requirements and how you can contribute to the company's goals of innovation and compliance.

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Inclusive & Diverse
Empathetic
Collaboration over Competition
Growth & Learning
Transparent & Candid
Medical Insurance
Dental Insurance
Mental Health Resources
Life insurance
Disability Insurance
Child Care stipend
Employee Resource Groups
Learning & Development

To serve patients. Amgen strives to serve patients by transforming the promise of science and biotechnology into therapies that have the power to restore health or save lives. In everything we do, we aim to fulfill our mission to serve patients....

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Full-time, hybrid
DATE POSTED
April 22, 2025

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