Specialist Quality Control - LIMS implementation

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Remote with willingness to travel as needed up to 50% (NC Plant)

This position will support QC ELN Project, including but not limited to, system validation/qualification deployment, eProcedure qualification, instrument report parsing script qualification and master data templating associated with Laboratory System Upgrade (CIMS (Reagent Manager)/LMES (Smart Lab eProcedure).

• 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 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 QC Laboratories.

• Responsible for training the Client 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

Top 3 Must Have Skill Sets:

• Quality Control Systems implementation experience in the pharmaceutical industry is required.

Day to Day Responsibilities:

• Lead eProcedure qualification in LMES in support of QC Method Specific eProcedure creation/qualification project.
• Manage CIMS template requests for all QC Groups.
• Author, revise, and review documents and reports including SOPs, qualification reports, technical reports supporting QC Systems (LMES/CIMS).
• Lead training workshops for the Client NC site as each QC Laboratory system goes live in the production environment.

• Seniority level
  
  Mid-Senior level

• Employment type
  
  Contract

• Job function Other
• Industries Staffing and Recruiting and Biotechnology Research

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