Lab IT Analyst
2380 Conejo Spectrum St Suite 200, ION Thousand Oaks, CA 91320 US
Job Description
Description of Project:
A laboratory within the ARC Laboratory is moving from R&D to GMP lab testing. The project requires the following computer-controlled instrument workstations to be validated:
Instrument Type?
#?
Validation Scope?
Cellaca?
1?
Full from ground up (create all deliverables from scratch)?
Glomax?
1?
Full from ground up (create all deliverables from scratch)?
DDPCR?
4?
Full from ground up (create all deliverables from scratch)?
Nanodrop?
1?
Full from ground up (create all deliverables from scratch)?
NC-200?
2?
Update existing documentation, rerun test cases?
Microbeta?
1?
Update existing documentation, rerun test cases?
Cytoflex?
2?
Update existing documentation, rerun test cases?
Faxitron?
1?
Update existing documentation, rerun test cases?
Main Responsibilities
The Lab IT Analyst will partner with each computer-controlled instrument business owner and the project validation analyst to create/edit the following SDLC deliverables:
- Change Control Record in Veeva
- User Requirements Specification
- 21 CFR Part 11 and Annex 11 Assessment
- Configuration Specification
- Risk Assessment
- IQ, OQ, PQ Test Case creation and execution
The Lab IT Analyst will be responsible for the commissioning activities for each instrument type:
- Spec out and order a computer workstation
- Commission workstation/patch OS/add to proper AD group
- Data security/permissions modifications
- Setup on workbench, connect to network
- Installation and configuration of software
- Assist with end user trainings
- Lockdown USB portswith Atara policies
- TeamViewer tool install
- Acronis Imaging
- Set up Druva Backups
- Connect to NuGenesisfor file archiving
- SOP updates/creation (User, Admin, Maintenance)
- Assign/apply RFID tag; add to instrument inventorymatrix
- Add to ServiceNow CMDB, SARF, Inc. Mgmtmodules
- Transition support of workstations/software to the steady state support team
Skills:
Preferred Knowledge Of and Experience With:
- Valgenesis
- Nugenesis
- Veeva Quality Docs
- ServiceNow
- Druva Backup Tool
- Acronis Imaging Tool
- TeamViewer Installation and Use
- Blue Mountain RAM
- Active Directory policy assignment
- Applying OS vulnerability patches
- IT System Administration Knowledge for the following instrument software types:
- Cellaca
- Glomax
- DDPCR
- Nanodrop
- NC-200
- Microbeta
- Cytoflex
- Faxitron
- Data Integrity
- 21CFRPart 11
- GDP, GMP, GLP, GCP
- Validation of computer controlled instruments
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