Specialist, Quality Control

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).

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.