IT Lab Validation Analyst
2380 Conejo Spectrum St Suite 200, ION Thousand Oaks, CA 91320 US
Job Description
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 IT Lab Validation Analyst will partner with each computer-controlled instrument business owner, the Quality Validation Lead and the Lab IT Analyst to create/edit the following SDLC deliverables:
Validation Deliverables?
Change Control Record
New Supplier Request to Qualify Vendors
User and IT Administration SOPs?
Validation Determination?
Validation Plan?
User Requirements Specification?
21 CFR Part 11 and Annex 11 Assessment?
Risk Assessment?
Configuration Spec?ification
IOPQ Validation? Protocol and Test Cases
IOPQ Validation Summary Report?
Requirements Trace Matrix?
Validation Plan Summary Report?
Skills:
Preferred Knowledge Of and Experience With:
- Valgenesis
- Nugenesis
- Veeva Quality Docs
- ServiceNow
- Druva Backup Tool
- Acronis Imaging Tool
- Blue Mountain RAM
- Knowledge/experience with 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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