Exact Sciences Corporation

IT Quality Assurance Validation Analyst

Job Locations US-WI-Madison
Req No.
2021-9080
Category
IT
Type
Regular Full-Time

Summary of Major Responsibilities

The IT QA Validation Analyst is responsible for providing quality assurance and computer systems validation support activities across the IT department of Exact Sciences. The IT QA Validation Analyst will contribute to the development of standard processes and procedures for software applications and computer systems that are managed by IT. The IT QA Validation Analyst is responsible for implementing and maintaining these standard processes and contributing to IT process improvement projects. This role interacts with cross-functional groups across Exact Sciences to ensure the IT quality processes align with the quality processes in other areas of the business.

Essential Duties and Responsibilities

  • Collaborate with cross-functional groups across IT and other areas of the business to develop and maintain standard processes and procedures for both regulated and non-regulated IT assets, software applications, and computer systems, including Change Management processes and Release Management processes.
  • Support the Change Management of software applications and computer systems by participating in the planning and review of change-related activities.
  • Facilitate regulatory compliance and impact assessments for IT assets, software applications, and computer systems.
  • Contribute to the maintenance of the computer system inventory.
  • Contribute to the creation and governance of local validation and compliance documents that support GMP validation, computer systems validation, and SDLC, utilizing good documentation practices for IT assets, software applications, and computer systems.
  • Support Validation teams across the business in the qualification, maintenance, and re-qualification of regulated IT assets, software, and systems.
  • Perform/review system assessments, validation protocols, test scripts.
  • Ensure that validation and qualification activities are compliant and consistent with company validation policies and procedures.
  • Provide training on our quality SOPs and the SDLC and computer system validation processes.
  • Support continuous process improvement efforts relating to computer systems validation, software development, and change management.
  • Identify opportunities and make constructive suggestions to improve process effectiveness to heighten quality.
  • Regularly communicate status and progress of validation/qualification activities to all relevant stakeholders.
  • Provide assistance to other team members.
  • Strong verbal and written communication skills.
  • Strong organization skills.
  • Self-starter, well organized; excellent presentation and interpersonal skills; effective facilitation skills; capability to resolve difficult problems.
  • Ability to work within a fast-paced, cross-functional team environment.
  • Adaptable, open to change and able to work in ambiguous situations and respond to new information or unexpected circumstances.
  • Uphold company mission and values through accountability, innovation, integrity, quality, and teamwork.
  • Support and comply with the company’s Quality Management System policies and procedures.
  • Maintain regular and reliable attendance.
  • Ability to act with an inclusion mindset and model these behaviors for the organization.
  • Ability to work on a mobile device, tablet, or in front of a computer screen and/or perform typing for approximately 90% of a typical working day.

Qualifications

Minimum Qualifications

  • Bachelor’s Degree in Health Sciences, Information Technology, or field as outlined in the essential duties; or High School Diploma or General Education Degree (GED) and 4 years of relevant experience in lieu of Bachelor’s Degree.
  • 4+ years of experience in biotech, pharmaceutical, or biological industries.
  • 3+ years of validation experience in quality assurance, computer systems validation, or business analysis.
  • Demonstrated understanding of change management, release management, and quality risk management concepts.
  • Demonstrated success in developing and implementing processes/best practices within software quality and information technology.
  • Proficient in Microsoft Office programs, such as Word, Excel, PowerPoint, and Outlook.
  • Demonstrated ability to perform the essential duties of the position with or without accommodation.
  • Authorization to work in the United States without sponsorship.

Preferred Qualifications

  • Experience in FDA-regulated or GMP-regulated industry.
  • Basic understanding of Quality Management System (QMS) requirements.
  • Demonstrated ability to organize and present technical information with minimal assistance.
  • Capable of resolving complex, multifaceted problems.

We are an equal employment opportunity employer. All qualified applicants will receive consideration for employment without regard to age, color, creed, disability, gender identity, national origin, protected veteran status, race, religion, sex, sexual orientation, and any other status protected by applicable local, state, or federal law. Applicable portions of the Company’s affirmative action program are available to any applicant or employee for inspection upon request.

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