QC Specialist LIMS - Holly Springs NC
QC Specialist LIMS - Holly Springs NC
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$ 126322 - 126322
1 Vacancy
Job Description
At Amgen if you feel like youre part of something bigger its because you are. Our shared missionto serve patients living with serious illnessesdrives all that we do.
Since 1980 weve helped pioneer the world of biotech in our fight against the worlds 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 youll 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 awardwinning culture is collaborative innovative and science based. If you have a passion for challenges and the opportunities that lay within them youll 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
Lets do this! Lets 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 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.
Additional Qualifications/Responsibilities
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
Associates degree and 8 years of Computer System Validation or System Administration experience OR
Bachelors degree and 4 years of Computer System Validation or System Administration experience OR
Masters 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 wellbeing. From our competitive benefits to our collaborative culture well 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 salesbased incentive plan
Stockbased longterm incentives
Awardwinning timeoff plans
Flexible work models including remote and hybrid work arrangements where possible
Salary Range
100929.00 USD 126322.00 USD
Required Experience:
Unclear Seniority
Employment Type
Full Time
