Software QA Analyst 2.0

The Software Quality Assurance Analyst 2.0 plays a crucial role in the quality assurance process, taking on complex testing tasks and contributing to the continuous improvement of testing practices, with a focus on 21 CFR Part 11 compliance. This position requires a meticulous and proactive individual with a strong understanding of software testing methodologies, excellent problem-solving skills, and the ability to work collaboratively with cross-functional teams.

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• SQA Process Development: Lead the definition of SQA processes to maintain a formally validated status for Slope’s software platform, ensuring compliance with 21 CFR Part 11.
• Test Scenario Preparation: Develop user-centered test scenarios based on system knowledge, Slope user role permissions, and product requirements to validate logic, error handling, and system workflows of pre-release features.
• Test Execution: Perform thorough manual and automated tests on new and existing software features, including functional, regression, integration, and performance testing.
• Defect Management: Identify, isolate, reproduce, track, and communicate defects using bug tracking tools. Verify fixes to ensure defects are resolved and do not reoccur.
• Test Planning and Strategy: Develop, implement, and maintain comprehensive test plans, test cases, and test scripts based on product requirements and specifications.
• SQA Documentation: Create and maintain detailed documentation of testing processes, test cases, results, and software quality metrics, as well as traceability and validation evidence to ensure transparency, accountability, and compliance with 21 CFR Part 11.
• Feature Assessment: Participate in the definition of new features to evaluate the scope of required testing scenarios and ensure software meets desired performance, reliability, functionality, and compatibility standards.
• Continuous Improvement: Collaborate with developers, product managers, the quality department and other stakeholders to continuously improve testing process, tools, and methodologies. Identify and recommend product improvements for future development consideration.
• Risk Assessment: Conduct risk assessments and provide recommendations for improving software quality and mitigating potential risks.
• User Experience Testing: Ensure the software meets user expectations in terms of usability, accessibility, and overall user experience.
• Training and Mentorship: Provide guidance and mentorship to junior QA Analysts, fostering a culture of quality and continuous learning within the team.
• Documentation Production: Lead the production activities for documentation to prove the formally validated status of the Slope software platform.
• Other duties as assigned.

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Education

• Bachelor’s degree in computer science, information technology, or related field, or equivalent work experience.

Experience

• Minimum of 3 years of experience in software quality assurance or a related role, including automated testing responsibilities.
• Minimum of 1 year experience in API testing using tools such as Postman.
• Experience with Agile Life Cycle Management Software (e.g., Jira, Azure DevOps, VersionOne).
• Experience with Quality Management Software (e.g., Xray, QTP, TestMo, Zephyr).
• Experience with software quality assurance and validation processes subject to 21 CFR Part 11 regulations.

Knowledge, Skills & Abilities

• Proficiency in test automation tools and frameworks (e.g., Selenium, QTP, Junit, Cypress, Cucumber).
• Proficiency with API test tools such as Postman.
• Strong knowledge of programming languages (e.g., Ruby, Java, Python) and scripting.
• Familiarity with Agile and Scrum methodologies.
• Excellent analytical and problem-solving skills.
• Strong attention to detail and organizational abilities.
• Effective communication and interpersonal skills.
• Ability to work independently and as part of a team.
• Proficiency with online collaboration tools necessary for collaboration with geographically dispersed teams (e.g., Slack, Zoom, MS Teams).

Preferred Qualifications

• Proficiency in Ruby programming language.
• Certification in Quality Assurance (e.g., ISTQB, CSTE).
• Experience with performance testing tools (e.g., LoadRunner, JMeter, NeoLoad).
• Familiarity with software logging tools (e.g., Splunk, Elastic).
• Knowledge of continuous integration/continuous deployment (CI/CD) pipelines.
• Understanding of cloud-based testing environments.
• Experience in healthcare and FDA-regulated environments.

Slope is a global provider of biospecimen lifecycle software, data, and services for clinical trials. With a focus on tech-enabling the full biospecimen lifecycle, Slope offers expertise that empowers sponsors to make informed decisions using high-quality, real-time sample data. Slope has supported thousands of the most complex, sample-intensive trials worldwide and has been adopted by 75% of NCI-designated cancer centers.Slope’s biospecimen lifecycle software solution, Biospecimen360™, provides sponsors with real-time, compliant, and traceable sample metadata to inform timely study decisions. The software controls sample metadata capture and orchestrates multi-stakeholder activities and data flow throughout the biospecimen lifecycle — from kit logistics and inventory control to sample collection, processing, storage, and shipping, to receipt at labs. The result is instant data availability across sites, labs, kitters, shippers, and other eClinical systems; this in turn enables faster reconciliation, less risk, and significantly improved study compliance, monitoring, and reporting.

Slope has a fun, high-energy, fast-paced environment full of motivated, purpose-driven employees who practice our core values on a daily basis:

1. Patients are paramount
2. Better, faster, stronger
3. Driven by data
4. Job done, have fun
5. Get Sloped!

• Health insurance
• Dental and vision coverage
• Flexible spending accounts
• Healthcare savings accounts
• Employee-funded supplemental life insurance
• Employee-funded short and long-term disability insurance
• 401(k) plan
• Nine paid holidays
• 15 PTO days
• Annual home office stipend