What are the responsibilities and job description for the Specialist Quality Control (ELN, computerized laboratory systems) position at Infotree Global Solutions?
Description:
Local holly springs, NC hybrid candidate to report to site when needed.
Typically Monday–Friday, 8:00 AM to 5:00 PM. May require occasional overtime or weekend hours based on project timelines.
Manager is open to aptitude over depth of experience if candidate shows promise.
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 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:
- Experience with implementing new computerized laboratory systems.
- Leadership experience
- Ability to work independently
Day to Day Responsibilities:
- Support ELN project as representative. Will perform all work in electronic system required to implement change to system at site level.
