GLP Quality Assurance Specialist

The Quality Assurance (QA) Specialist will work with Neuralink's teams to ensure that the appropriate governing body regulations are followed. This includes, but is not limited to, adherence to ISO standards and the GLPs. Responsibilities will include: - Maintaining copies of all approved protocols - Maintaining a master schedule of all GLP-regulated studies - Performing pre-qualification inspections of the testing facilities as needed - Providing general periodic status reports to management and the study director pertaining to facility, quality control, and preclinical study compliance - Inspecting and auditing at studies at critical phases and communicating findings to appropriate management - Determining that no deviations from approved protocols or standard operating procedures were made without proper authorization and/or documentation - Reviewing study protocols to ensure compliance before study initiation - Verifying that final study reports accurately reflect the raw data, protocol, methods, and SOPs used in conducting the GLP study and preparing a Quality Assurance Statement to be included in the report - Writing and reviewing Quality Assurance SOPs - Reviewing equipment, software, and other computer-system validations and qualifications when applicable - Inspecting critical vendors - Ensuring personnel training records are maintained by staff - Conduct GLP training for staff as needed - Serving as a point of contact and assisting with FDA inspections.