Sr Associate Quality Control I

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.

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.

• 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 ​

• 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.
• Experience with stability operations, QC sample management, laboratory start-up, equipment or method qualification and validation, method transfer, or change-control records.
• Experience with technical writing, controlled procedures and reports, vendor coordination or IOQ, employee training, or providing guidance to teammates.
• Familiarity with LIMS, LMES or CIMS, Veeva, TrackWise, and Smartsheet. Knowledge of aseptic technique is preferred when relevant to assigned work.
• Clear written and verbal communication, sound organization, independent work on routine tasks, and effective collaboration across teams.

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 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.

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.

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 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. We make all employment decisions without regard to race, color, religion, sex or any other characteristic protected by applicable law.

We provide reasonable accommodations to applicants and employees with disabilities, consistent with legal requirements. Please contact us to request accommodation.