QC Specialist (LIMS)

Career Category

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.

QC Specialist (LIMS)

What you will do

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

In this vital role, you will support deployment, validation, and system administration of Laboratory Systems (LIMS/Reagent Manager/Smart Lab eProcedure). The Specialist, Quality Control LIMS Specialist, will report directly to the Manager of Quality Control Support. This role may manage QC Support staff.

• Support templating in LIMS ANC environment for all EM/Continuous Monitoring, Validation/Engineering, NPI and Routine Material templates.

• Lead eProcedure qualification in LMES in support of ANC QC Method Specific eProcedure creation/qualification project.

• Manage CIMS template requests for all ANC QC Groups.

• Provide incident management support as required.

• Identify operational gaps and propose solutions.

• Drive the QC Laboratory Systems equipment integration to LMES for all ANC QC Laboratories.

• Responsible for training the Amgen NC site as each QC Laboratory system goes live in the production environment.

• Author, revise, and review documents and reports including SOPs, qualification reports, technical reports.

• Lead planning, scheduling, and execution of QC Laboratory Systems daily activities.

• Lead validation and change management support for ANC Laboratory systems deployment.

• Support routine activities over the weekends and Amgen holidays as needed.

What we expect of you

We are all different, yet we all use our unique contributions to serve patients. The Manager of Quality Control Support seeks a dynamic, flexible, and driven individual with these qualifications.

Basic Qualifications:

• High school diploma / GED and 10 years of Computer System Validation or System Administration experience

• Associate’s degree and 8 years of Computer System Validation or System Administration experience OR

• Bachelor’s degree and 4 years of Computer System Validation or System Administration experience OR

• Master’s degree and 2 years of Computer System Validation or System Administration experience OR

• Doctorate degree

Preferred Qualifications:

• Strong technical Laboratory Systems knowledge required to support deployment and support of Laboratory systems (LIMS/Reagent Manager/Smart Lab eProcedure).

• Degree in Microbiology, Biology, Biochemistry, or related scientific field.

• Strong CSV experience with QC Laboratory systems.

• Strong written and verbal communication skills, including technical writing and technical presentations.

• Able to flexibly work independently, as a project owner, collaboratively on group tasks, and as a trainer.

What you can expect from 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 compreh