Overview

We’re looking for a smart, detail-oriented and creative software validation and quality engineer or associate who will be motivated by being part of a high-caliber team building meaningful software products for our bio-pharma customers. You will be responsible for validating our cloud-based platform and participating in quality process development. Highly motivated candidates with strong fundamentals but without prior validation experience are encouraged to apply. This positions reports into our Quality Department.

Job responsibilities:

  • Develop and execute software development lifecycle validation deliverables including: validation plans and reports, user and functional requirements, and validation testing protocols (IQ, OQ, PQ)
  • Communicate with quality, technology, and professional services departments regarding quality and validation issues
  • Write and maintain standard operating procedures (SOPs) and templates
  • Develop and maintain quality management system training materials
  • Conduct training sessions

The ideal candidate has:

  • The ability to think carefully and precisely with great attention to details
  • Strong communication skills (both written and verbal)
  • Strong interpersonal skills
  • Passion for software quality and validation methods
  • A good intuition for prioritizing and applying time and resources
  • The desire to provide great service to internal and external customers
  • The ability to handle multiple, rapidly changing and competing priorities
  • A BA/BS degree at minimum
  • Knowledge and experience with system/software development lifecycle and change control
  • Knowledge of and experience in validation or testing of software / SaaS
  • Knowledge of ISO-9001, GAMP-5, ITIL standards is a plus
  • Knowledge of clinical trials or experience in pharma/medical device quality (GXP, 21CFR11, etc.) is a plus
  • Expertise with Word, Excel and PowerPoint

Reasons why you may want to pursue this opportunity:

  • Work with motivated, smart, efficient and committed people
  • See virtually all aspects of a growing, entrepreneurial company
  • Build knowledge in an area that is essential to the health of society and critical to bio-pharma companies running clinical trials
  • Build knowledge in software development life cycle, quality standards and validation processes and methods
  • Work on quality process development and improvement

Reasons we will be interested in you:

  • You are enthusiastic, dedicated and smart–you fit our culture
  • You have a passion for quality process development
  • You are a crisp and precise thinker
  • You can “zoom in and zoom out”, one minute discussing a detail of the software functionality, the next discussing quality audits and risk assessment
  • You learn and grow quickly
  • You can work independently
  • You are good at explaining quality processes, validation methodology and industry quality standards
  • You are or have the potential to be very efficient at performing validation and maintaining a quality management system
  • You have fun performing software and systems validation

To apply, please email your resume to careers@trialnetworks.com, along with a solution to the following exercise:

Write a list of test cases for a feature that allows a user to set his or her password where the password rules are:

Minimum 8 characters; whitespace not allowed; must include at least one character from 3 of the 4 character sets listed below:

  • Upper case characters
  • Lower case characters
  • Numbers
  • Special characters

About TrialNetworks

 TrialNetworks provides s sponsors and CROs with the award-winning Clinical Trial Optimization System to transform clinical operations quality and efficiency. Customers use this modern and intuitive technology to improve key aspects of a trial from feasibility through closeout. TrialNetworks is located in Newton, MA and is part of DrugDev.  Visit http://www.trialnetworks.com for more information 

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