Specialist Quality Control

Job Description

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.
  

The Planet Group of Companies is an equal opportunity employer. We celebrate diversity and are committed to creating an inclusive environment for all employees.