Quality Assurance Specialist

Team Description:

Join the Quality Systems Team, where our mission is to ensure compliance with relevant regulatory standards by streamlining operations and enhancing efficiency through innovative process development. We are a group of industry-experienced professionals who utilize creative problem-solving to establish efficient systems for compliance. Our vision is to set internal quality standards that exceed FDA expectations. We seek a dynamic individual who thrives on continuous improvement and is passionate about implementing systems that drive compliance and optimize performance.

Job Description and Responsibilities:

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, Good Laboratory Practices (GLP), clinical guidelines, manufacturing protocols, and quality control practices. 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 intervals adequate to ensure the integrity of the data and verify applicable compliance
• Communicating the findings of all QA inspections to appropriate management via signed inspection reports
• 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
• Preparing a Quality Assurance Statement to be included in final reports
• 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, such as for new hires or when training certifications have expired
• Serving as a point of contact and assisting with FDA inspections

Required Qualifications:

• Bachelor of Science degree, preferably in a science, engineering, or quality-related discipline
• Minimum of 1 year of experience in a medical device or life sciences organization
• Minimum of 1 year of experience within a regulatory environment
• Minimum of 1 year of experience with FDA regulations and requirements
• Basic computer skills and proficiency in Google Docs, Google Drive, and Gmail
• Ability to travel to/from work in multistate locations

Preferred Qualifications:

• Experience auditing multiple GxP processes
• Experience with auditing quality control testing
• Strong understanding of the scientific method and engineering first principles
• Understanding within the fields of microbiology and chemistry
• Excellent organization and communication skills
• Keen eye for detail

Work Environment: Office, lab, operating room, and animal care facilities