Description We are in search of a Quality Assurance Analyst to join our team in Salem, New Hampshire. This role involves ensuring compliance with GxP and regulatory requirements, leading computer systems validation efforts, and providing expertise in Labware LIMS within regulated environments. This job offers a long-term contract employment opportunity.

Responsibilities:

• Lead and manage computer systems validation efforts for various GxP projects.

• Ensure proper computer systems validation procedures are followed during system implementations in line with GxP and regulatory requirements.

• Develop business requirements and documentation based on GAMP 5 methodologies, ensuring alignment with industry best practices.

• Oversee project documentation throughout the software development life cycle.

• Review and approve executed validation documents for GxP applications, with a focus on Labware LIMS.

• Conduct risk assessments for GxP applications and processes, identifying potential compliance issues and implementing mitigation strategies.

• Oversee test execution and provide solutions for deviations during protocol executions.

• Train project team members on proper computer systems validation documentation, testing practices, and the use of automated document management systems.

• Provide guidance to IT and other departments regarding 21 CFR Part 11 regulations, ensuring the applicability and adherence to system controls.

• Review and assess computer controls and Part 11 applicability for laboratory environments, ensuring compliance with regulatory standards. Requirements • Proficiency in computer systems

• Experience in system validation

• Knowledge of validation testing, rules, models, and plans

• Familiarity with software validation and data validation

• Understanding of GxP regulations

• Experience in business analysis

• Proficiency in using Laboratory Information Management System

• Ability to create and manage analysis documentation and project documentation

• Experience in risk assessment, specifically business risk assessment

• Ability to conduct and perform security risk assessments

• Experience in test execution. Technology Doesn't Change the World, People Do.®

Robert Half is the world’s first and largest specialized talent solutions firm that connects highly qualified job seekers to opportunities at great companies. We offer contract, temporary and permanent placement solutions for finance and accounting, technology, marketing and creative, legal, and administrative and customer support roles.

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All applicants applying for U.S. job openings must be legally authorized to work in the United States. Benefits are available to contract/temporary professionals, including medical, vision, dental, and life and disability insurance. Hired contract/temporary professionals are also eligible to enroll in our company 401(k) plan. Visit roberthalf.gobenefits.net for more information.

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