Specialist Quality Control

Planet Group
Holly Springs, NC


Pay range: 30-40/hr
*depending on experience

The ideal candidate will have at least 4 years of experience supporting the implementation or validation of electronic quality systems, preferably within a GMP-regulated pharmaceutical or medical device environment. They should be comfortable working independently, possess strong technical documentation skills, and have hands-on experience building, configuring, or validating systems, not just using them. Prior involvement in global or cross-functional IT system projects is preferred.

This position will support QC ELN 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 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.
Posted 2025-08-06

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