Role Description The QA Specialist provides independent Quality support for GLP and GCLP studies by performing document review, protocol and experiment record review, data review, and quality event oversight activities. The role focuses on ensuring data integrity, traceability, and compliance with internal SOPs and applicable regulatory expectations, while maintaining strict independence from study execution. This position includes high‑value QA activities that can be performed remotely, with controlled system access and clear separation from operational responsibilities. - Study-Audit Support - Support execution of internal audits by: - Create study-specific audit schedule prior to First patient-in (FIP) for study-specific audit - Create audit plan, execute, and draft the report for each scheduled audit (interim or associated with the final report) using objective, evidence-based language under QA lead oversight - Execute the audit through the review of controlled documents, including: - SOP alignment - Version verification - Study governing documents (Lab manual, Project Specification Document, Data Transfer Agreement, clinical protocol) - Conduct QA review of clinical protocols, sample analysis protocols (SAP/SAR) and amendments, ensuring: - Version verification - Internal consistency - Alignment with study objectives and SOPs - Assure closure of quality events pertaining to study at the time of data reporting - Perform QA review (sampling) of experiment records / batch records, including: - Need access to LIMS/BSI and other systems hosting data source - Ensure alignment between protocol-defined activities and recorded execution - Training status of staff - Qualification status of equipment and reagents - Conduct QA review (sampling) against DTA of data tables, listings, and summaries, including: - Table-to-source traceability (raw data → output) - Internal consistency checks - Sample ID reconciliation and data alignment (BSI) - Apply data integrity (ALCOA+) principles during review of electronic data systems - Computerized Systems Audit Support - Support execution of internal audits by: - Preparing audit checklists - Compiling pre-audit document packages - Assisting with document-based audit reviews - Provide audit preparation support, including: - Evidence list preparation - Pre-audit document collection - Draft audit reports and summaries using objective, evidence-based language under QA lead oversight - Data Integrity Assessment - Conduct data integrity audits of paper and electronic records - Evaluate: - Audit trails and metadata - System controls (e.g., access, security, validation) - Data lifecycle controls (collection, processing, reporting) - Assess compliance with: - ALCOA+ principles - 21 CFR Part 11 / Annex 11 for electronic systems - Identify: - Data discrepancies, manipulation risks, or gaps - System vulnerabilities affecting data reliability - Miscellaneous: - Assist in training new and existing personnel, as needed - Participate in regulatory, notified body, and customer audits as needed - Provide back-up coverage for other Quality Specialists - Carry out other duties/projects as assigned Qualifications - Bachelor’s Degree or Master Degree in Life Sciences, Pharmacy, Biology, Chemistry - 4 years of related experience in a life science GxP environment with CRO experience preferred - Hands-on experience with: - ICH-GCP (E6 R2/R3) - FDA regulations (e.g., 21 CFR Part 11) - EMA / EU CTR / Annex 11 - GxP frameworks (GCP, GMP, GLP, GCLP) - Preferred certification: - ASQ Certified Quality Auditor (CQA) - ISO 9001 / ISO 13485 Lead Auditor - GxP Lead Auditor certifications (e.g., CQI/IRCA) - Clinical QA certifications (e.g., CCQAP) Requirements - High attention to detail - Strong written and verbal communication - Ability to meet deadlines and perform administrative functions - Data review expertise across computerized systems including LIMS - Understanding of Audit trails, metadata, and system validation - Knowledge of Computer System Validation (CSV) and Computer System Assurance (CSA) - Data governance frameworks - Must be able to interpret raw data vs reported data discrepancies - Microsoft Office suite proficiency including Office Word, Excel, PowerPoint - Ability to organize tasks, work independently and adapt to changing priorities - Ability to function independently within a minimally supervised environment with exceptional attention to detail required - Demonstrated highly developed communication skills including well-developed writing skills and verbal and interpersonal skills - Must be able to read, write, speak, fluently and comprehend the English language Company Description

• Develop and execute detailed manual test plans and test cases for the SIMBA Team, ensuring strong functional coverage across core user flows and edge cases. • Perform hands-on manual testing across browsers and devices to validate new features, bug fixes, and releases. • Collaborate closely with engineers and product teams to identify, reproduce, isolate, and document defects, providing clear steps, expected vs. actual results, and supporting evidence. • Maintain clear and organized QA documentation, including test cases, regression suites, test reports, and release validation summaries. • Partner with Product, Engineering, and Customer Support to ensure issues are triaged correctly and prioritized based on user impact. • Participate in Agile workflows including daily standups, sprint planning, grooming, and retrospectives, ensuring QA is embedded throughout the development lifecycle. • Execute regression testing and release validation to ensure product quality and stability prior to launch. • Continuously identify ways to improve manual QA processes, test coverage, and communication between teams.

• Develop and execute detailed manual test plans and test cases for the SIMBA Team, ensuring strong functional coverage across core user flows and edge cases. • Perform hands-on manual testing across browsers and devices to validate new features, bug fixes, and releases. • Collaborate closely with engineers and product teams to identify, reproduce, isolate, and document defects, providing clear steps, expected vs. actual results, and supporting evidence. • Maintain clear and organized QA documentation, including test cases, regression suites, test reports, and release validation summaries. • Partner with Product, Engineering, and Customer Support to ensure issues are triaged correctly and prioritized based on user impact. • Participate in Agile workflows including daily standups, sprint planning, grooming, and retrospectives, ensuring QA is embedded throughout the development lifecycle. • Execute regression testing and release validation to ensure product quality and stability prior to launch. • Continuously identify ways to improve manual QA processes, test coverage, and communication between teams.

Title: QA Engineer Automated III Job Description: Category Information Technology Clearance Required None Overview JOB TITLE: QA Engineer Automated III CAYUSE COMPANY: Cayuse Civil Services, LLC LOCATION Hybrid, Austin, TX SALARY: $79,040.00-$112,320.00 EMPLOYEE TYPE: Full-Time Salary Exempt TRAVEL No RELOCATION No Employment in this role is conditional upon successful execution of the contract by the client. The Work The QA Automation Engineer is responsible for designing, developing, and executing automated tests to validate the quality and performance of enterprise applications. The engineer creates and maintains automated test scripts and frameworks, prioritizes and plans test scenarios, and develops documentation to support all automated testing processes. This position aligns with Cayuse’s core values of excellence, innovation, and accountability by delivering high-quality, efficient, and scalable automated testing solutions, ensuring timely and successful project execution in hybrid work environments. Responsibilities - Design, develop, and maintain automated test cases using Playwright or similar automation frameworks. - Develop, maintain, and execute test scripts for both automated and manual testing efforts. - Determine test scenario priorities and create detailed test execution plans. - Perform manual testing as required to supplement automated coverage. - Track and report on test case execution status, defects, and overall test coverage. - Establish and manage regular automated test execution schedules and associated reporting. - Use Jira to log, track, and manage defects through resolution. - Develop and maintain requirements traceability matrices to ensure complete test coverage. - Collaborate and coordinate with development and project teams in development, test, UAT, and production environments. - Troubleshoot and debug test scripts, test data, and environment issues as needed. - Lead and coordinate User Acceptance Testing (UAT) activities as required. - Provide on‑call support as needed to address critical testing or production issues. - Create and maintain documentation for automated testing processes, standards, and best practices. - Operate effectively within an Agile environment, participating in ceremonies and aligning testing activities with iterative delivery. - Other duties as assigned. Qualifications Here’s What You Need The qualifications and skills listed below are intended to provide a general overview of the requirements for this position. However, due to the anticipated nature of the contract and the absence of a finalized task order from the client, this list should not be considered all-encompassing. Additional qualifications, certifications, skills, or experience specific to the client’s requirements may be identified and requested upon award of the task order. Candidates should demonstrate flexibility and a willingness to adapt to evolving responsibilities as outlined by the client. - 10+ years – Required: Manual test script execution experience. - 8+ years – Required: Automated QA testing experience. - 8+ years – Required: QA test script creation experience. - 8+ years – Required: Performance testing experience. - Must be able to pass a background check. May require additional background checks as required by projects and/or clients at any time during employment. Desired Qualifications: - 5+ years – Preferred: QA automated test case reporting experience. - 5+ years – Preferred: JavaScript and HTML experience; familiarity with Playwright, WebdriverIO, and JMeter. - 3+ years – Preferred: Experience in Agile/Scrum environments and using tools such as Jira, Xray, or Zephyr. - 3+ years – Preferred: Accessibility testing experience. Our Commitment to you / overview of benefits - Medical, Dental and Vision Insurance; Wellness Program - Flexible Spending Accounts (Healthcare, Dependent Care, Commuter) - Short-Term and Long-Term Disability options - Basic Life and AD&D Insurance (Company Provided) - Voluntary Life and AD&D options - 401(k) Retirement Savings Plan with matching after one year - Paid Time Off Reports to: Program Manager Working Conditions - Professional hybrid office environment. - Ability to work on-site in Austin, TX. - Must be physically and mentally able to perform duties extended periods of time. - Ability to use a computer and other office productivity tools with sufficient speed to meet the demands of this position. - Must be able to establish a productive and professional workspace. - Must be able to sit for long periods of time looking at computer screen. - May be asked to work a flexible schedule which may include holidays. - May be asked to travel for business or professional development purposes. - May be asked to work hours outside of normal business hours. Other Duties: Please note this job description is not designed to cover or contain a comprehensive list of activities, duties or responsibilities that are required of the employee for this job. Duties, responsibilities, and activities may change at any time with or without notice. Cayuse is an Equal Opportunity Employer. All employment decisions are based on merit, qualifications, skills, and abilities. All qualified applicants will receive consideration for employment in accordance with any applicable federal, state, or local law. Pay Range USD $79,040.00 - USD $112,320.00 /Yr.