Document Control Specialist

Quality Systems  ·     Austin, Texas    ·    Full time

Neuralink is seeking a highly motivated document control professional to establish, build and lead the documentation system covering multiple quality system aspects such as version control, file management, and managing batch & training records. As a key member of the Quality Systems group, the individual will work closely with cross-functional groups to develop and implement efficient and effective GxP compliant document control processes and scale them upwards to be software controlled. 

About you

• Meticulous attention to detail and strong organizational skills
• Effective multitasking skills
• Great verbal and written communication skills
• Ability to thrive in a dynamic and constantly changing environment
• Ability to work effectively and collaboratively in a cross-disciplinary team environment
• Willing and eager to go above and beyond/flexible schedule

Key Responsibilities

• Organize GxP data files into the traceable and trackable system
• Issue and manage data logs for labs, audits, equipment, etc.
• Maintain a working knowledge of FDA CFR requirements (21 CFR 11, 21 CFR 58 and 21 CFR 812) to establish real-time support for GxP operations
• Develop and scale quality assurance document management system and procedures
• Sustain and improve document control quality system towards automation
• Backroom lead for FDA/external audits
• Project management and task management
• Negotiating and building relationships with organizations
• Management and oversight of internal and vendors records

Key Qualifications

• Evidence of exceptional ability in organization skills, problem-solving and critical thinking
• 1-3 years of experience in FDA regulated industry
• Strong understanding of Google Suite (Google Documents, Google Sheets, etc.)
• Working knowledge of medical and scientific terminology.
• Demonstrated communication and organizational skills to thrive in a dynamic and cross-functional, fast-paced environment.
• Strong technical writing skills

Preferred Qualifications 

• Bachelor’s Degree in Administrative field
• Experience in the medical device industry or regulatory affairs
• Prior experience in building or maintaining a document control program

What we offer:

• An opportunity to change the world and work with some of the smartest and the 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; parental leave.
• Flexible time off + paid holidays.
• Equity + 401(k) plan.
• Commuter Benefits.
• Meals provided.

Neuralink provides equal opportunity in all of our employment practices to all qualified employees and applicants without regard to race, color, religion, gender, national origin, age, disability, marital status, military status, genetic information or any other category protected by federal, state and local laws.  This policy applies to all aspects of the employment relationship, including recruitment, hiring, compensation, promotion, transfer, disciplinary action, layoff, return from layoff, training and social, and recreational programs. All such employment decisions will be made without unlawfully discriminating on any prohibited basis.

Multiple studies have found that a higher percentage of women and BIPOC candidates won’t apply if they don’t meet every listed qualification. Neuralink values candidates of all backgrounds. If you find yourself excited by our mission but you don’t check every box in the description, we encourage you to apply anyway!