GLP Quality Assurance Specialist
About The Position
We are creating devices that enable a bi-directional interface with the brain. These devices allow us to restore movement to the paralyzed, restore sight to the blind, and revolutionize how humans interact with their digital world. 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.
Requirements
- 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
Nice To Haves
- 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
Responsibilities
- 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
Benefits
- An opportunity to change the world and work with some of the smartest and most talented experts from different fields
- Growth potential; we rapidly advance team members who have an outsized impact
- Excellent medical, dental, and vision insurance through a PPO plan
- Paid holidays
- Commuter benefits
- Meals provided
- Equity (RSUs) Temporary Employees & Interns excluded
- 401(k) plan Interns initially excluded until they work 1,000 hours
- Parental leave Temporary Employees & Interns excluded
- Flexible time off Temporary Employees & Interns excluded
Stand Out From the Crowd
Upload your resume and get instant feedback on how well it matches this job.
What This Job Offers
Job Type
Full-time
Career Level
Entry Level
