Sr Associate Quality Control I

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. Amgen is advancing a broad and deep pipeline and portfolio of medicines to treat heart disease, obesity and obesity-related conditions, rare diseases, inflammatory conditions and cancer. 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 QUALITY CONTROL I

What you will do

Let’s do this. Let’s change the world. In this vital role you will support ANC QC Sample Management and Stability operations, including site start-up and ongoing program delivery. The role establishes and executes sample-handling and stability processes, coordinates requests and protocol-timed activities, protects sample integrity, and supports laboratory equipment and computerized-system readiness. The role prepares accurately controlled documentation and supports qualified testing, validation, and method or knowledge transfers. It manages routine work with minimal supervision, resolves issues within training and authorization, and promptly escalates complex quality or timeline risks.

· Receive, identify, track, store, transfer, retain, and dispose of QC samples under approved procedures; maintain chain-of-custody and records in LIMS and other approved systems.

· Coordinate stability requests with Global Stability Coordinators and Product Quality Leads; manage assigned clinical and commercial drug substance and intermediate materials and complete pulls, processing, study starts, and placement within approved protocol timelines.

· Protect stability-sample integrity through required storage conditions, study segregation, and backup controlled-temperature chamber readiness.

· Support lab start-up and readiness by establishing workflows and preventive maintenance, supporting equipment and system installation, qualification, and validation, coordinating vendors and IOQ, and assisting with procurement and method or knowledge transfers.

· Perform assigned sample-management procedures and routine QC testing after qualification; operate equipment, review data, resolve routine issues, and escalate complex or quality-impacting concerns.

· Prepare and review SOPs, methods, safety assessments, trend and technical reports, and qualification or validation summaries; follow cGMP, good documentation practices, and safety requirements.

· Support audits, investigations, and change control; coordinate priorities and status with QC, Manufacturing, and stability partners; contribute to improvements and mentor or orient team members.

Role expectations:

· Performs assigned routine procedures with minimal supervision after qualification; manages samples carefully; maintains assigned equipment; resolves routine issues and escalates complex problems.

· Understands assigned equipment and systems; uses approved tools independently for day-to-day work; shares learning, mentors newer team members, consults peers, and contributes to continuous improvement.

· Follows cGMP, SOP, safety, and documentation requirements; completes work carefully and accurately; identifies and reports issues and contributes practical procedure input.

· Models Amgen values, patient focus, and ethical conduct; maintains a constructive professional approach; asks for feedback and takes accountability for quality results.

· Understands how assigned tasks support site and team goals; align priorities and timeframes with partners; keeps a work schedule and adjusts priorities as directed.

· Completes agreed work on time, communicates progress and availability, and offers help when shared work is at risk of falling behind.

What we expect of you

We are all different, yet we all use our unique contributions to serve patients. The professional we seek is a person with these qualifications.

Basic Qualifications:

• High school/GED + 4 years of Quality work experience OR​
• Associate’s + 2 years of Quality work experience OR​
• Bachelor’s + 6 months of Quality work experience​ OR
• Master's ​

Preferred Qualifications:

• Bachelor’s degree in a related scientific field such as chemistry, microbiology, molecular biology, physics, or engineering.
• Additional experience in a GMP pharmaceutical or biopharmaceutical laboratory, with analytical testing, stability operations, or QC sample-management work.

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