Quality Assurance Specialist

1 day, 1 hour ago
Full-time
Junior
Quality Assurance and Testing
Neuralink

Neuralink

Neuralink is pioneering the development of brain-computer interfaces aimed at restoring autonomy for individuals with unmet medical needs while also seeking to unlock human potential through a high-bandwidth, generalized interface to the brain.

Biotechnology
251-1K
Founded 2016
$643M raised

Description

  • Conduct GLP audits and support GMP, GCP, and engineering audits when needed.
  • Review evidence, identify compliance concerns or deviations, and document findings.
  • Verify that approved protocols and standard operating procedures are followed and properly authorized.
  • Communicate QA inspection findings to management through signed inspection reports.
  • Track deviation and audit findings and support timely closure of corrective actions.
  • Maintain the master schedule for GLP-regulated studies and approved protocols.
  • Support compliance initiatives and continuous quality improvement projects.
  • Ensure personnel training records are maintained.
  • Assist with FDA inspections.

Requirements

  • Bachelor of Science degree, preferably in a science, engineering, or quality-related discipline.
  • Exposure to a regulated environment such as FDA-regulated industry, GxP, ISO, or quality systems work.
  • Working knowledge of FDA regulatory requirements and standards.
  • Excellent communication and collaboration abilities.
  • Basic computer skills with proficiency in Google Docs, Google Drive, and Gmail.
  • Ability to travel to and from work in multistate locations.
  • Internship, co-op, or up to 1 year of experience in a medical device, pharmaceutical, or life sciences organization (preferred).
  • 1+ years of experience auditing (preferred).
  • 1+ year of experience within a regulatory environment (preferred).
  • Experience with external agency audits, such as FDA or other notified bodies (preferred).
  • Experience following SOPs and documenting work accurately in a controlled process (preferred).
  • Working knowledge of the scientific method and engineering first principles (preferred).
  • Excellent organization and communication skills (preferred).
  • Keen eye for detail (preferred).

Benefits

  • Hourly range of $26.92 to $44.71 USD in Texas.
  • Excellent medical, dental, and vision insurance through a PPO plan.
  • Paid holidays.
  • Commuter benefits.
  • Meals provided.
  • Equity in the form of RSUs for eligible employees.
  • 401(k) plan for eligible employees.
  • Parental leave for eligible employees.
  • Flexible time off for eligible employees.

Interested in this position?

Apply directly on the company website

Apply Now

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