Validation Business Analyst Vacancies in LS Solutions Inc. Palo Alto, CA

Website LS Solutions Inc.

This Jobsfunter Listing is about LS Solutions Inc in Palo Alto, CA 2022

About the job

ROLE: VALIDATION/BUSINESS ANALYST

LOCATION: Palo Alto, CA

DURATION: 1 year with extension

ESSENTIAL DUTIES AND RESPONSIBILITIES:

· Expert in Requirement Analysis / System Specification Analysis on Clinical systems.

· Experience in drafting the following documents as a Business Analyst – Process Flow Diagrams, Storyboard discussion documents, Requirement Specifications, Workflow Use Cases.

· Excellent knowledge of testing methodologies, strategies, and Software Development Life Cycle (SDLC).

· Experience authoring validation deliverables – Validation Plans, Test Plans, Validation reports, IQ/OQ/PQ test scripts, Deviation/Incident Reports and Change Controls.

· Excellent experience in Change Management

· Experience in developing test scenarios, managing Defects, reviewing/updating Requirements Specifications for all functionalities of configurable systems including Role based Security, Field configurations, Electronic Signatures, Audit Trail and Interfaces.

· Excellent working knowledge of tools like MS Visio, MS PowerPoint, MS Word and MS Excel.

· Thorough knowledge of GxP Regulations (21 CFR Part 11, 211, 820) and 21 CFR Part 11 and Data Integrity

· Demonstrated capabilities to quickly gain a detailed understanding of a process in order to optimize efficiencies, reduce cost, and improve quality.

Qualifications:

· Validation and Business Analysis experience in Life Sciences industry

· Experience gathering requirements, developing requirements documentation, and executing testing

· Experience with Etmf, CTMS, eCOA and other clinical trial applications strongly preferred. Needs to be a quick learner if no experience on these apps.

Company: LS Solutions Inc.

Vacancy Type: Contract 

Job Location: Palo Alto, CA

Application Deadline: N/A

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