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Senior Analyst Computer Software Validation

Company: NeoGenomics Laboratories
Location: Carlsbad
Posted on: April 10, 2021

Job Description:

Are you motivated to participate in a dynamic, multi-tasking environment? Do you want to become part of a company that invests in its employees? Are you seeking a position where you can use your skills while continuing to be challenged and learn? Then we encourage you to dive deeper into this opportunity. NeoGenomics is looking for a Senior Analyst, Computer Software Validation who wants to continue to learn in order to allow our company to grow. Now that you know what we're looking for in talent, let us tell you why you'd want to work at NeoGenomics: As an employer, we promise to provide you with a purpose driven mission in which you have the opportunity to save lives by improving patient care through the exceptional work you perform. Together, we will become the world's leading cancer reference laboratory. Position Summary: As the Senior Analyst, CSV you will plan, drive and execute Computer Software Validation and Part 11 processes to validate systems to ensure that they comply with applicable regulations, international standard, and industry best practices. Write technical documents including specifications, risk assessment, test protocols and report to establish and maintain the validated state throughout the system life cycle in line with regulatory agencies including the FDA. Conducting activities as required per GAMP5 and approved procedures of NeoGenomics. The validation efforts also expected to include validation of equipment with software used within the Quality System. Responsibilities: --- Establishing Validation Plan--- Identifying and documenting software requirements (both User Requirements and Functional Requirements)--- Identifying and documenting software design for customized systems, and software configuration for purchased systems--- Establishing test protocols to verify all requirements--- Documenting traceability between requirements, design and tests--- Executing test protocols and capturing objective evidence of test results--- Documenting Validation summary reports--- Planning and executing data migration--- Planning and supporting system implementation upon validation completion Requirements: --- Experience with planning and executing computer software validation within the medical device industry. Specifically require experience with enterprise wide software systems and equipment with software.--- Experience understanding and applying the FDA's requirements for electronic records and signatures (Part 11) Education: Bachelor's degree or equivalent years of experience is required. Master's preferred5+ years' experience planning and executing computer software validation within the medical device industry, lab, or regulated environment. Qualifications: --- Effective communication skills, written and verbal--- Experience working in a fast paced environment--- Self-directed, able to work effectively with limited oversight--- Demonstrated change management experience supporting company during a culture change - such as establishing a quality system where they had not previously been, or significant change to processes.--- Effective communication skills, written and verbal--- Experience working in a fast paced environment--- Self-directed, able to work effectively with limited oversight--- Ability to travel 20% between Carlsbad and Aliso Viejo offices Certificate Compliance/Desired Skills: --- CSV Related certifications are preferred

Keywords: NeoGenomics Laboratories, San Diego , Senior Analyst Computer Software Validation, IT / Software / Systems , Carlsbad, California

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