Computer Validation Specialist

Berkeley, California | Contract

Post Date: 05/16/2017 Job ID: 14629 Industry: QA

Computer Validation Specialist
Berkeley, CA

Currently have an opening in Berkeley, CA for a Computer Validation Specialist.

Responsibilities will include:

  • Perform analytical computerized instrument and software validation, spreadsheet validation and validation periodic review to support a variety of the labs within QC organization. 
  • Prepare IOQ and other life cycle documents with high quality and accuracy. 
  • Write validation protocols and final reports and function as a validation of SME.
  • Conduct computer and software validation, validation periodic review. 
  • Ensure validations are within compliance by following industry standards, corporate policy, and regulatory requirement. Interact with regulatory agencies, customer, and internal auditors/inspectors as needed. Support regulatory filings with documentation as needed. 
  • Write and/or revise SOPs, and maintain all validation related documentation. 
  • Manage multiple projects with ability to trouble shoot and seek solution. 

Computer Validation Specialist Requirements

  • Bachelor’s Degree in Science or Engineering 
  • 4+ years’ experience in performing analytical computerized instrument and software validation. 
  • Strong understanding of cGMP, 21 CFR Part 11, global regulatory compliance. 
  • Knowledge of validation principles, including user requirements, system specifications, IQ, OQ, and PQ. 
  • Strong understanding of data integrity 
  • Strong technical/business writing and communication skills. 
  • Knowledge of risk assessment, gap analysis, changes control and deviation management. 
  • Strong computer skills, including Word, Excel, PowerPoint and databases. 
  • Excellent organizational skills, capable of multi-tasking and creating validation/qualification documents for multiple projects simultaneously.

 

Computer Validation Specialist - 14629

Travis Heider
IT Recruiter

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