12 months (likely extension)
- Our client is currently looking for a QC IT Systems Analyst to assist with ongoing project support with the development and execution of CSV deliverables within GxP computer systems. Lab systems administration applications will consist of systems such as: Chromeleon, Empower, SOLO VPE, LightCycler 480, Lonza WinKQCL, Roche Cedex, and other related systems.
- The project will require analytical and problem-solving skills where the selected resource will work with the team while they drive deliverables independently in addition to assisting with QMS activities, assessing change controls for impact on computer systems and applying CAPA’s. Day to day functions will involve writing IT validation documentation (IQ’s, System Administration Procedures, System Design & Configuration Specifications, etc.), audit trail reviews, and qualification/execution of CSV & SDLC processes. There will be various usage of computer tools in which working knowledge of MS Word & Excel will be required; experience with computer tools such as Labware LIMS, Unicorn, ELM Network, Empower, MSD, Nugenesis, SQL Databases, TCP/IP Networks, Windows Desktop & Server, Citrix, etc. will be helpful.
- At least 5+ years of hands-on experience with the job description is required.
Responsibilities will also involve (but not limited to):
- Operation IT & project supports for lab staff in various laboratory instruments across several sites.
- Root cause analysis, lab application user management, audit trail reviews, lab software management, system access reviews
- IT computer system validation support include change control implementation, authoring SOP’s, and qualifications
- Assessment of lab systems in which data objects are stored and protection methods and developing flow diagrams that justify data
- Validation process support: Risk assessments, IQ/OQ/PQ’S, User Requirement Specifications
- Collaborate with infrastructure teams to request server architecture and execute installation of applications
MA: Senior IT Lab Systems Analyst (233746)