Sr. QA Validation Analyst

Help us change lives

At Exact Sciences were helpingchange how the world prevents detects and guides treatment for cancer. We give patients and clinicians the clarity needed to make confident decisions when they matter most. Join our team to find a purpose-driven career an inclusive culture and robust benefits to support your life while youre working to help others.

Exact Sciences Corporation seeks Sr. QA Validation Analyst in Madison WI.

Job Duties: Collaborate with cross-functional groups across IT and other areas of the business to create and maintain standard processes and procedures for both Qualified and non-Qualified Assets software applications and computer systems including Change Management processes and Release Management processes. Facilitate software applications and computer systems Change Management by participating in the planning implementation and verification and validation of the change. Develop and maintain quality metrics for software applications and computer systems supported by IT. Implement standard risk and impact assessment methods and metrics for IT assets software applications and computer systems. Draft and maintain 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 include SOPs qualification protocols gap assessments risk assessment Impact Assessment user requirements functional and configuration specifications requirements traceability validation plans validation summary reports and change controls. Develop and provide training on our SDLC and computer system validation processes and SOPs. Support continuous process improvement efforts relating to computer systems validation and software development and change. Identify opportunities and make constructive suggestions for change to improve process effectiveness to heighten quality. Support Validation teams across the business in the qualification maintenance and requalification of Qualified IT assets software and systems. Maintain inventory of Qualified 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. Work with internal IT partners to understand infrastructure architecture and framework to ensure regulatory requirements are met. Regularly communicate status and progress of validation/qualification activities to the Director IT Program Management and Quality Systems Validation. Remote work benefit available. Employee can work from anywhere in the U.S.

Minimum Requirements: Bachelors degree or foreign equivalent in a health-related science engineering information technology or technology related field and 5 years of experience as a Senior QA Validation Analyst Quality Validation Analyst Quality Analyst or a role/capacity engaged in computer systems validation.

Special Skills:

• 5 years of validation experience in computer systems validation in an FDA-regulated or GMPregulated industry.
• 5 years of experience utilizing or applying Change Management Release Management and Quality Risk Management concepts.
• 5 years of experience in developing reviewing and executing validation and change control documents authoring SOPs and validation protocols (IQ OQ and PQ).
• 5 years of experience in technical writing for SOPs and other lab validation documentation.
• 5% domestic travel required. Remote work benefit available. Employee can work from anywhere in the U.S..

Salary: $102107 - $155000 per year. Please apply at or by email at with reference to: Job #: R25-10042.

#LI-DNI

Salary Range:

Exact Sciences is proud to offer an employee experience that includes paid time off (including days for vacation holidays volunteering and personal time) paid leave for parents and caregivers a retirement savings plan wellness support and health benefits including medical prescription drug dental and vision coverage. Learn more about our benefits.

Our success relies on the experiences and perspectives of a diverse team and Exact Sciences fosters a culture where all employees can develop personally and professionally with a sense of respect and belonging. If you require an accommodation please contact us here.

Not ready to apply Join our Talent Community to stay updated on the latest news and opportunities at Exact Sciences.

We are an equal employment opportunity employer. All qualified applicants will receive consideration for employment without regard to disability protected veteran status and any other status protected by applicable local state or federal law.

To view the Right to Work E-Verify Employer and Pay Transparency notices and Federal Federal Contractor and State employment law posters visit our compliance hub. The documents summarize important details of the law and provide key points that you have a right to know.