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IT Lab Validation Analyst

Thousand Oaks, CA 91320

Posted: 10/16/2023 Employment Type: Contract Job Category: Scientific Job Number: 586216 Is job remote?: No Country: United States

Job Description

Duties:
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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About Thousand Oaks, CA

Ready to take your career to the next level in the vibrant city of Thousand Oaks, California? Nestled in the heart of Ventura County, this bustling city offers a perfect blend of suburban charm and urban amenities. With a strong job market, top-notch schools, and breathtaking views of the Santa Monica Mountains, Thousand Oaks is an ideal location for professionals seeking growth and fulfillment. Explore job opportunities near iconic sites like the Gardens of the World, catch a show at the Fred Kavli Theatre, or indulge in the local culinary scene featuring dishes from around the world. Join this dynamic community and unlock your potential in Thousand Oaks! Start your job search now to find your perfect fit in this captivating city.

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