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The Steely Group
http://www.thesteelygroup.com
http://www.thesteelygroup.com
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Specialist, Quality Control
Posted: 06/12/2025
2025-06-12
2025-07-15
Employment Type:
Contract
Job Category: Quality
Job Number: 4483
Job Description
This Specialist, Quality Control position will support the QC ELN (Electronic Lab Notebook) Project, including but not limited to, system validation/qualification deployment, eProcedure qualification, instrument report parsing script qualification and masterdata templating associated with Laboratory System Upgrade (CIMS (Reagent Manager)/LMES (Smart Lab eProcedure).
Basic Qualifications:
- Support validation/qualification deployment
- Lead eProcedure qualification in LMES in support of Global QC Method Specific eProcedure creation/qualification project.
- Manage CIMS template creation for Global QC method specific reagents/ and ANC consumables.
- Provide incident management support as required.
- Support application performance monitoring and label printing issues.
- Identify operational gaps and propose solutions.
- Assist in the execution of QC Laboratory Systems equipment integration for all ANC QC Laboratories.
- Responsible for training the Amgen NC site as each QC Laboratory systems go 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.
Basic Qualifications:
- Doctorate degree OR Masters degree and 2 years of experience OR Bachelors degree and 4 years of experience OR Associates degree and 8 years of experience OR High school diploma / GED and 10 years of experience
- Quality Control Systems implementation experience in the pharmaceutical industry is required.
- Experience implementing systems within QC including electronic laboratory notebooks, LIMS, and reagent management systems.