Quality Validation Business Analyst

Thermo Fisher; United Kingdom; Remote; GBP 45,000 - 70,000; Full time

Job summary

A global leader in scientific solutions is seeking a Quality Validation Business Analyst to ensure software releases meet validation standards. This role involves creating validation tests and collaborating with Agile teams. Candidates should have a Bachelor's degree in a related field and 5+ years of experience in software validation. This is a home-based, 2-year fixed-term position located in the UK.

Qualifications

• 5+ years of experience in a software validation or quality assurance role.
• Experience with risk assessment approaches.
• Familiarity with Agile methodologies.

Responsibilities

• Contribute to governance principles and ways of working.
• Collaborate with Agile delivery teams.
• Create and monitor validation tests.

Skills

Proven experience in a software validation or quality assurance role

Regulatory and Compliance Experience

Focus on Business Analysis Skills

Clarify Process Automation

Excellent problem-solving skills and attention to detail

Education

Bachelor's degree in computer science, engineering, or a related field

Tools

Azure Dev Ops

Cosmos DB

.NET Core

React

Playwright

Cypress

Job description

Overview

Work Schedule: Standard (Mon-Fri)

Environmental Conditions: Office

Job Description

As the world leader in serving science, Thermo Fisher Scientific solves the world's toughest problems, like giving cancer patients hope, ensuring water and food are safe, helping law enforcement solve cases through forensics and most recently, serving as the largest provider of COVID-19 solutions.

Our IT, Data and Tech careers are a unique opportunity to apply your niche skills and advanced experience in analytics, statistics, data science, programming, product management and information technology to drive our Mission of enabling our customers to make the world healthier, cleaner, and safer. It''s truly a career where your work makes a positive impact in our world. When you join Thermo Fisher Scientific, you''ll make an impact inside and outside the company on work that matters. #TechWithPurpose

The PPD clinical research business of Thermo Fisher Scientific is a leading provider of global CRO solutions. We provide comprehensive drug development, laboratory and lifecycle services to customers across pharmaceutical, biotechnology, medical device, academic and government entities. By harnessing innovative technology and expertise, we work to empower our customers to bring therapies to market, faster.

We have an exciting opportunity to join our Clinical Innovation team as a Quality Validation Business Analyst, who is responsible for ensuring that software releases meet the required validation standards. This includes requirements transfer into change control systems, organizing and running risk assessments for requirements, identifying and writing validation testing scripts, and maintaining a comprehensive understanding of the validation process, required artefacts, and the requirements capture and change control system. The role also involves monitoring the execution of validation tests and responding to feedback or questions from those performing the tests. Additionally, the Quality Validation Analyst will promote and help implement a shift-left mindset and approach to validation testing.

Our Platform/Tool Set:

• Work Management and CI/CD: Azure Dev Ops
• Change Control System: In-house developed and implemented
• Developed Software: Cosmos DB, .NET Core, React, Azure Cloud
• Testing Framework: Playwright, Cypress

Key Responsibilities:

• Contribute to our governance, principles, and ways of working.
• Collaborate with Agile delivery, product managers, designers, and engineers.
• Requirements transfer to Change Control systems
• Risk Assessment organization and monitoring.
• Validation test creation, organization and execution monitoring.
• Collaboration with testing team members on automation of validation tests.
• Validation process monitoring and reporting.
• Shift-left promotion and implementation.

This is a 2-year fixed term position, home-based for candidates in the UK.

Education and Experience:

• Bachelor's degree in computer science, engineering, or a related field or equivalent and relevant formal academic / vocational qualification
• Previous experience in a software validation or quality assurance role that provides the knowledge, skills, and abilities to perform the job (comparable to 5+ years' experience)
• In some cases an equivalency, consisting of appropriate education, training, and/or directly related experience will be considered sufficient for an individual to meet the requirements of the role.

Knowledge, Skills and Abilities:

• Proven experience in a software validation or quality assurance role.
• Regulatory and Compliance Experience: experience in regulated environments and familiarity with compliance standards
• Focus on Business Analysis Skills: transfer from User Stories, risk assessment, and process documentation.
• Clarify Process Automation: automating validation processes (e.g., using PowerShell)
• Validation Focus: focus on validation processes, documentation, and ensuring compliance rather than software testing.
• Experience with risk assessment approaches.
• Familiarity with Agile methodologies and working in Agile teams.
• Proficiency in writing validation testing scripts.
• Knowledge of requirements capture and change control systems.
• Solid understanding of software development methodologies.
• Excellent problem-solving skills and attention to detail.

Nice to have:

• Knowledge of TDD, BDD including unit test, integration and E2E testing.
• Familiar with both Azure and Azure DevOps.
• Certifications:
  • Certified Software Quality Analyst (CSQA).
  • Certified Quality Auditor (CQA).
  • Certified Validation Professional (CVP).

At Thermo Fisher Scientific, we are committed to fostering a healthy and harmonious workplace for our employees. We understand the importance of creating an environment that allows individuals to excel. Please see below for the required qualifications for this position, which also includes the possibility of equivalent experience:

• Able to communicate, receive, and understand information and ideas with diverse groups of people in a comprehensible and reasonable manner.
• Able to work upright and stationary for typical working hours.
• Ability to use and learn standard office equipment and technology with proficiency.
• Able to perform successfully under pressure while prioritizing and handling multiple projects or activities.
• May require as-needed travel (0-20%).