Sr. QA Validation Analyst

EXACT SCIENCES CORPORATION • Madison, WI • 1d ago

JOB REQUIREMENTS: 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: Bachelor\'s 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: (1) 5 years of validation experience in computer systems validation in an FDA-regulated or GMPregulated industry. (2) 5 years of experience utilizing or applying Change Management, Release Management, and Quality Risk Management concepts. (3) 5 years of experience in developing, reviewing, and executing validation and change control documents, authoring SOPs, and validation protocols (IQ, OQ, and PQ). (4) 5 years of experience in technical writing for SOP\'s and other lab validation documentation. 5% domestic travel required. Remote work benefit available. Employee can work from anywhere in the U.S.. Salary: \$102,107 - \$155,000 per year. Please apply at https://careers.exactsciences.com/ or by email at TalentSourcing@exactsciences.com with reference to: Job #: R25-10082 ** OTHER EXPERIENCE AND QUALIFICATIONS: Minimum Requirements: Bachelor\'s 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: (1) 5 years of validation experience in computer systems validation in an FDA-regulated or GMPregulated industry. (2) 5 years of experience utilizing or applying Change Management, Release Management, and Quality Risk Management concepts. (3) 5 years of experience in developing, reviewing, and executing validation and change control documents, authoring SOPs, and validation protocols (IQ, OQ, and PQ). (4) 5 years of experience in technical writing for SOP\'s and other lab validation documentation. 5% domestic travel required. Remote work benefit available. Employee can work from anywhere in the U.S.. Salary: \$102,107 - \$155,000 per year. ** APPLICATION INSTRUCTIONS: E-Mail a Rsum: TalentSourcing@exactsciences.com Apply Online: https://careers.exactsciences.com/

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