Software QA Tester (Life Sciences/21 CFR Part 11 Compliance)

$65,000 - $80,000/Yr

Metrum Research Group - Simsbury, CT

Full-time - Mid Level

Remote - Simsbury, CT

Professional, Scientific, and Technical Services

About the position

As a Software QA Tester at Metrum Research Group, you will be integral in ensuring the quality and compliance of software solutions tailored for the life sciences industry. This role involves collaborating with product teams and developers to execute test plans, identify issues, and ensure adherence to regulatory standards such as 21 CFR Part 11. You will be responsible for designing and implementing test procedures that validate the functionality, reliability, and security of software applications, contributing to the overall success of our clients in regulated industries.

Responsibilities

• Develop comprehensive test plans and test cases based on functional and regulatory requirements outlined in 21 CFR Part 11.
• Conduct validation testing to ensure that software changes and updates comply with regulatory requirements and do not adversely impact system integrity.
• Execute test cases manually and using automated testing tools to validate software functionality, performance, and security in alignment with industry best practices (i.e. GAMP 5, PIC/S).
• Document, track, and ensure the resolution of change controls and issues related to software changes using the company's eQMS.
• Document and track defects and bugs, and work closely with development teams to investigate, troubleshoot, and resolve issues promptly.
• Perform risk assessments and assist in the development of risk mitigation strategies related to software quality and compliance.
• Collaborate with cross-functional teams to review and refine software requirements, designs, and user stories from a quality and compliance perspective.
• Collaborate with QA group to proactively identify upstream and downstream issues.
• Participate in sprint meetings with cross-functional teams to help ensure procedures and controls are followed throughout the software development lifecycle.
• Stay updated on industry trends, best practices, and regulatory changes related to software quality assurance and cGxP compliance.

Requirements

• Bachelor's degree in Computer Science, Engineering, or related field.
• Minimum of 5 years of experience in software quality assurance, with a focus on regulatory compliance in industries governed by cGxP.
• Proficiency in automated testing tools and scripting languages (e.g., Python, R, Selenium).
• Strong understanding of cGxP regulatory requirements and their application to software development and validation processes.
• Experience designing, implementing, and executing test plans and test cases for complex software systems in alignment with GAMP 5 requirements.
• Experience in QA methodology.
• Experience with agile/scrum methodologies and continuous integration/continuous deployment (CI/CD) pipelines.
• Excellent analytical and problem-solving skills, with the ability to prioritize tasks and work effectively in a fast-paced environment.
• Strong communication skills and the ability to collaborate effectively with cross-functional teams.

Nice-to-haves

• 1-2 years of shell scripting or programming experience.
• 1-2 years with basic SQL.
• Adept with Atlassian product suite and ZenQMS a plus.
• Experience with IDEs and modeling software (MATLAB, Monolix etc) a plus.

Benefits

• Opportunities for advancement
• Flexible work environment with remote work options
• Competitive salaries
• Excellent benefits package