Associate Quality Control- Incoming

Career Category

Quality

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 lie within them, you’ll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career.

Associate Quality Control - Incoming

What you will do

Let’s do this. Let’s change the world. In this vital role the successful candidate will work with a team responsible for the Incoming Quality Control sampling and inspection processes of primary/secondary components, devices and raw materials. In addition, will be responsible for raw material sample shipments, testing and batch record's review per standard operating procedures or guidelines. Will also work cross-functionally to support multiple customers and stakeholders including Supply Chain, Quality Assurance, Process Development, Engineering and Quality Control.

Specific responsibilities include but are not limited to:

• Complete onboarding and all required training qualifications.
• Perform routine sampling and inspection of raw materials, components, drug substances/products, devices, and printed materials.
• Collaborate with Supply Chain Procurement, QA, Dispensing, Receiving, Shipping, and Packaging teams to ensure daily warehouse operations are well coordinated between each function.
• Operate laboratory equipment such as Optical Comparator, Keyence, Instron, TruScan and NIR for testing and inspection tasks.
• Use computer systems (e.g., LIMS, OEFM, SAP) to manage sample testing, document results, and support related activities.
• Evaluate test results in accordance with established SOPs and analytical methods.
• Review electronic batch record documentation for incoming raw materials and components.
• Identify and recommend process improvements for routine functions; implement changes upon approval.
• Troubleshoot process and/or testing issues in compliance with SOPs and escalate when necessary.
• Participate in regulatory inspections and internal/external audits.
• Perform cleaning and sanitization of classified areas and prepare disinfectant solutions.
• Train and qualify new staff to ensure consistent performance of assigned tasks.

What we expect of you

We are all different, yet we all use our unique contributions to serve patients. The Associate Quality Control professional we seek is an individual contributor with these qualifications.

Basic Qualifications:

• High school/GED + 2 years of work experience in Quality Control

OR

• Associate’s + 6 months of work experience in Quality Control

OR

• Bachelor’s degree

Preferred Qualifications:

• Ishihara certification  

• Educational background in Life Sciences or Engineering 

• Strong knowledge and understanding of GMP, regulatory requirements, written procedures, methods and safety guidelines
• Basic knowledge and experience in sampling and inspection processes for raw material, components, drug substance, drug product and devices per procedures and regulations. 

• Strong skills in systems such as SAP/ERP, eBR, LIMS, Trackwise, Coldstream, Veeva and applications such as Smartsheet among others

• Problem-solving approach with the ability to support investigations and recommend improvements 

• Strong verbal and written communication skills 

• Intermediate proficiency with Microsoft Office (Word, Excel, PowerPoint, databases) 

• Strong time management and task prioritization skills in a fast-paced environment 

• Flexibility to support non-standard shifts, including weekends 
• Good communication skills and presentation skills, (both written and verbal).
• Ability to work in a team environment, to collaborate and coordinate with internal and external staff at all levels, and to prioritize multiple responsibilities, tasks and projects simultaneously.

• Commitment to Amgen’s values and a quality-first culture 

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

Apply now and make a lasting impact with the Amgen team.

careers.amgen.com

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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.

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.

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