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Altasciences
Everettt, WA, United States
2 days ago
Altasciences
Everett, WA, United States
2 days ago
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Seattle, Washington, United States
5 days ago
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Bothell, WA, United States
30+ days ago
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Seattle, WA, United States
30+ days ago
Zymeworks
Seattle, WA, United States
30+ days ago
Altasciences
Everettt, Washington, United States
2 days ago

Description

Altasciences is a mid-size contract research organization with a unique focus on supporting drug development from lead candidate selection to proof of concept. With over 25 years of industry experience, we provide preclinical and clinical solutions to an international customer base of biopharmaceutical companies. Our full-service offering in this critical stage of drug development includes program management, preclinical safety testing, clinical pharmacology services, manufacturing and analytical services, medical writing, biostatistics, data management, and bioanalysis services tailored to specific research requirements. Altasciences has facilities in Montreal, QC; Kansas City, KS,Seattle, WA and Philadelphia, PA.
 
Our team is made up of over 1,300 professionals from the medical and scientific fields who work together to achieve a common goal: to contribute to the advancement of life sciences. Bring your talents and forward-thinking approach to Altasciences and help us develop medicines for those who need them, faster.

The Validation Specialist is responsible for performing a suite of tests (functional, security, Inputs, outputs and other) on software as well as coordinating upgrades / modifications / customizations of software for both internal and external-COTS systems, in order to ensure that they are compliant with applicable regulatory guidelines , operational workflows and procedures. The Validation Analyst II produces the documentation to support the computer systems validation (CSV) process; which is subject to revision and evaluation by various regulatory and governmental agencies (FDA, TPD, EU or other). The Validation Analyst II will work directly with users to establish user requirements as well as relevant risk assessments, etc. The Validation Analyst II will be able to work independently on many aspects of the CSV process as well as being able to complete simple validation projects with minimal supervision. In addition they will be able to present and defend the CSV position towards clients and agencies, as required.
 


Responsibilities:

  • Define and coordinate the execution of the validation of COTS software or internally developed systems; according to industry standards: FDA, TPD, etc.
  • Compile and assist in the development of the functional and specific user needs based on the GxP use of software/system
  • Complete simple CSV validations independently
  • Work directly with users, ITOPS and Quality Assurance on many CSV validation coordination aspects Assess the compliance of systems with FDA 21 CFR part 11 and EU Annex 11
  • Development and execution of test scenarios (Tests Scripts) and test reporting documentation as per CSV/GAMP5 models
  • Assist the Quality Assurance Department during client audits and/or agency audit for issues concerning the CSV validation of computer systems. In addition can defend and present the CSV position for clients, sponsors and agencies.
  • Other related tasks as required


Requirements

  • AA or above degree in IT or scientific fields or equivalent experience. 5 years of experience in software development SDLC quality assurance
  • Basic knowledge of software design standards and standard test
  • Knowledge of MS Office and software testing tools (Rational Visual test – would be an asset
  • Good communication with internal and external customers


Altasciences is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, or national origin, and protected veteran status, or disability status.
 
Altasciences  uses E-Verify to confirm the employment eligibility of all newly hired employees. To learn more about E-Verify, including your rights and responsibilities, please visit www.E-Verify.gov.

Job Information

  • Job ID: 57906535
  • Location:
    Everettt, Washington, United States
  • Position Title: Computer Systems Validation Specialist
  • Company Name: Altasciences
  • Job Function: Technical Operations
  • Job Type: Full-Time
  • Min Education: Associates Degree
  • Min Experience: 5-7 Years

Please refer to the company's website or job descriptions to learn more about them.

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