Job Title:
Senior Software Quality Validation Specialist
About Us:
Cold Chain Technologies (CCT) is a leading manufacturer and provider of thermal packaging solutions to the pharmaceutical, biotech, health care and medical device industries. We are a technically advanced, financially secure company with more than 50 years of experience and a history of vigorous growth.
CCT is ISO 9001 registered and is headquartered in Franklin, MA with a global manufacturing and distribution network including facilities in MA, TN, TX, PA, IL, CA and a global footprint in the Netherlands, United Kingdom, Spain, Brazil, Australia and India. Our affiliated design and testing laboratories are highly recognized throughout the industry as world-class.
Job Description:
The Senior Software Quality Validation Specialist will report to the Global Director of Quality. They will be responsible for ensuring that all the CCT and their partner’s software applications meet the required quality and regulatory standards through testing, documentation and compliance verification. This role will be responsible for developing, executing and documenting the validation protocols for software, systems, and processes. They will collaborate with cross-functional teams to ensure the software meets end users or market functional expectations and performance standards.
Primary Responsibilities:
- Maintain a technical understanding of all integrated systems supporting the digital platform and how they impact the business go-to market strategy.
- Creating and implementing test plans, test cases, and reports to validate software functionality and performance including test validation plans from the end user perspective.
- Coordinate testing both internally and with offshore supplier partners
- Verifying that software and systems adhere to regulatory requirements, industry standards, and company policies.
- Maintaining accurate and complete records of all validation processes, including test results, deviations, and corrective actions.
- Working with developers, testers, and other stakeholders to ensure software quality and compliance.
- Working with manufacturing sites to ensure that protocols are in place to support operators to interact with the software applications.
- Analyzing test results, identifying defects, and working with the development team to implement solutions.
- Leading activities to address customer complaints related to the software functionality, root cause investigation, corrective action implementation, and written response.
- Performing risk assessments and developing mitigation strategies related to validation activities,
- Tracking, analyzing, and reporting on validation activities to stakeholders along with recommendations for tactical and strategic improvements
- Staying up to date on the latest regulatory requirements, industry best practices, and testing methodologies.
Qualifications:
- Bachelor’s Degree or higher preferred; ideally in a related scientific discipline.
- Proficiency in software testing methodologies, test automation, and debugging.
- Experience with various testing tools and technologies, including test management systems and automation framework.
- Solid organizational and follow-up skills, as well as attention to detail.
- Ability to effectively communicate technical information to both technical and non-technical audiences.
- Ability to meticulously document validation activities and ensure accuracy.
- Ability to analyze test data, identify issues, and develop solutions.
- Familiarity with relevant regulations such as FDA, EMA, or ISO.
- Critical thinker with analytical problem-solving skills.
- Strong Collaboration Skills.
- Effectively manage multiple and changing priorities.
- Knowledge of nonconformance, CAPA, and other standard compliance systems.
- Ability to work in a very fast-paced environment.
- Work related travel required – domestic and international (up to 25%)
- Preferred Qualifications: Working knowledge of cGMP and GDP preferred
- Project Management (conducting status meetings, project reporting, etc) is a plus.
- Six Sigma Green Belt or Lean Certification
