1 day ago

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QC Specialist (LIMS) US - North Carolina - Holly Springs

Amgen

USOntarioRemote

Career Category

Operations

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 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. Amgen is an Equal Opportunity employer and will consider you without regard to your race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status.

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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Salary Range

100,929.00 USD - 126,322.00 USD