Comp. Sys Validation Spec

Natera•Boulder, CO

About The Position

Computer System Validation Specialist will work the Natera Software Engineering team to ensure appropriate software documentation is in place to support changes to Laboratory and Product software systems. Working with the QA Software Manager this position will provide value-added guidance throughout the software development lifecycle process.

Requirements

BS Degree or equivalent work experience
3-5 years’ experience within a dedicated CSV or product software validation role
Experienced working in a CLIA Laboratory environment and/or FDA regulated environment
Extensive knowledge of QA methodologies, test planning, system dependencies, and product integration phases.
Extensive knowledge of regulatory requirements for software design and change control (lifecycle management)
Knowledge of regulatory requirements for non-product and product software (IEC 62304, 21 CFR Part 11, 21 CFR Part 820.30 and 820.70(i), CLIA, etc.)
Strong knowledge of QA methodologies (such as root cause analysis), test planning, system dependencies, and product integration phases.

Nice To Haves

Preferred experience/knowledge with Microsoft Great Plains, Confluence, JIRA, SuccessFactors, LIMS, EDMS

Responsibilities

Participate in software risk management activities
Perform risk and/or impact assessments for Lab, Product, and Quality Management software systems
Review software change requests and maintenance updates along with associated test plans, protocols, and reports
Participate and/or lead computer system validation projects
Draft IQ/OQ/PQ software plans, protocols, and reports
Ensure validation state of software systems are maintained
Act as subject matter expert for CSV compliance during internal and external audits
Perform audit trail reviews
Participate and/or lead cross-functional teams to investigate and resolve software nonconformities, deviations, CAPAs, and complaints.
May support quality system audits as subject matter expert in computer system validation.
Responsibilities are assigned based on demonstrate competency.