What are the responsibilities and job description for the Specialist Quality Control (ELN/Implementation) position at Infotree Global Solutions?
Job Description:
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 Client 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 Client QC Laboratories.
• Responsible for training the Client 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.
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 Client QC Method Specific eProcedure creation/qualification project.
- Manage CIMS template requests for all Client QC Groups.
- Author, revise, and review documents and reports including SOPs, qualification reports, technical reports supporting Client NC QC Systems (LMES/CIMS).
- Lead training workshops for the Client NC site as each QC Laboratory system goes live in the production environment.
