GLP Quality Assurance Specialist

Team Description:

Join the Quality Assurance Team, where our mission is to ensure compliance with relevant regulatory standards and ensure functional, consistent, and reliable operation of our regulated processes.  We are a group of industry-experienced professionals who utilize creative problem-solving to identify gaps and help 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 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

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 GLP processes
• Experience with auditing
• 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