Specialist Quality Control (ELN/LMES/QC)

Infotree Global Solutions; Holly Springs (NC); On-site; USD 70,000 - 100,000; Full time

Job summary

A leading global solutions company seeks a Specialist Quality Control to support their QC ELN Project in North Carolina. This role involves system validation, managing eProcedure qualifications, and incident management in a dynamic and collaborative environment. Candidates should have experience in quality control systems within the pharmaceutical industry.

Qualifications

• Experience in implementing quality control systems in the pharmaceutical industry.

Responsibilities

• Lead eProcedure qualification in LMES for client QC method-specific projects.
• Manage CIMS template requests for all client QC groups.
• Train client staff as each QC laboratory system goes live.

Skills

Quality Control Implementation

Pharmaceutical Industry Experience

Incident Management

Job description

Specialist Quality Control (ELN/LMES/QC)

Be among the first 25 applicants. Direct message the job poster from Infotree Global Solutions.

Candidates should ideally be local, as onsite presence up to 50% may be required based on business needs.

This position supports the QC ELN Project, including system validation/qualification deployment, eProcedure qualification, instrument report parsing script qualification, and master data templating related to Laboratory System Upgrade (CIMS (Reagent Manager)/LMES (Smart Lab eProcedure)).

• Lead eProcedure qualification in LMES supporting global QC method-specific eProcedure creation and qualification.
• Manage CIMS template creation for global QC reagents and client consumables.
• Provide incident management support as needed.
• Support application performance monitoring and label printing issues.
• Identify operational gaps and propose solutions.
• Assist in executing QC Laboratory Systems equipment integration across all client QC laboratories.
• Train client staff as each QC laboratory system goes live in production.
• Author, revise, and review SOPs, qualification reports, and technical reports.
• Lead planning, scheduling, and execution of daily QC Laboratory Systems activities.

Top 3 Must-Have Skills: Experience in implementing quality control systems in the pharmaceutical industry.

Day-to-Day Responsibilities:

• Lead eProcedure qualification in LMES for client QC method-specific projects.
• Manage CIMS template requests for all client QC groups.
• Author, revise, and review documents supporting client QC systems (LMES/CIMS).
• Lead training workshops for client sites during system go-live.

Seniority level

Mid-Senior level

Employment type

Contract

Job function

Manufacturing

Industries

Staffing and Recruiting, Pharmaceutical Manufacturing