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

Join us at Metrum Research Group and be part of a talented team dedicated to delivering innovative software solutions that drive compliance, efficiency, and success for our clients in regulated industries. MetrumRG offers opportunities for professional growth and career advancement. We have a flexible work environment with remote work options. As part of our dynamic team, you will enjoy working in a collaborative and supportive culture with opportunities for professional growth and career advancement.

Company Overview: Metrum Research Group is a leading provider of clinical trial statistical analysis software solutions tailored for companies operating under the regulatory requirements of the life science industry (including but not limited to 21 CFR Part 11 regulations). We specialize in developing cutting-edge software products that ensure compliance, efficiency, and reliability for our clients in regulated industries such as pharmaceuticals, biotechnology, and medical devices.

Job Overview: As a Software QA Tester you will play a crucial role in ensuring the quality of our software offerings. You will collaborate closely with our product team, developers, and QA to execute test plans, identify issues, help ensure the quality of our technology solutions, and ensure compliance with industry standards. We are seeking a detail-oriented and proactive Software QA Tester with a strong understanding of regulatory requirements under cGXP (21 CFR Part 11, GAMP 5 PIC/S). In this role, you will be responsible for designing, implementing, and executing test plans and procedures to ensure the functionality, reliability, and security of our software applications. This position reports to the Director of Product Management. 

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.

Qualifications:

• 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.
• Please note: this job description is not meant to be all-inclusive. Other duties may be assigned.

Education and Experience:

• 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.
• 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.

Metrum Research Group offers competitive salaries and an excellent benefits package. You can read more about us on our website by clicking the link to our company careers page at the top of this page. Just click 'Company Website' on the left.

Metrum Research Group EEO Statement
MetrumRG believes that innovation is cultivated when we challenge each other with new ideas and perspectives. MetrumRG is an equal opportunity employer that is committed to building a diverse and inclusive team. All employment decisions are based on qualifications, merit, and business needs, and we prohibit discrimination and harassment of any kind based on race, color, sex, religion, sexual orientation, gender identity, national origin, disability, genetic information, pregnancy, or any other protected characteristic as outlined by federal, state, or local laws.
MetrumRG is committed to providing equal employment opportunities and reasonable accommodations for candidates and employees with disabilities. We encourage all qualified candidates to apply for positions within our organization. If you require reasonable accommodation because of a medical condition for the application or interview process, please contact Scotti Rylands or our Talent and Culture Department, (860)735-7043 x-622, or message us and we will work with you to meet your needs.