About the job Lab IT Analyst
Safebox is looking for an experienced Lab IT Analyst to move a clients laboratory from R&D to GMP lab testing.
Safebox is a boutique consulting organization focused on helping clients design and implement large-scale technology initiatives that deliver measurable outcomes and drive business value.
Primary 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 ports with client 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 inventory matrix
Add to ServiceNow CMDB, SARF, Inc. Mgmt modules
Transition support of workstations/software to the steady state support team
Knowledge 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
The following computer-controlled instrument workstations are to be validated:
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
Location: Onsite in Thousand Oaks, CA
Pay rate: $79.50/hr
Please note:
This is a 6 month contract role ending 3/25/24 with possibility for extension up to 12 months
Direct application only we do not accept staffing applications; no Corp to Corp
Must be eligible to work in the US; we do not sponsor Visas
Failure to answer all application questions may result in automatic rejection