QA Operations Specialist

We're Hiring: QA Operations Specialist!

We are looking for a detail-oriented and proactive QA Operations Specialist to join our team in Novato, United States. The ideal candidate will have a strong background in quality assurance processes and methodologies, ensuring that our products meet the highest standards of quality and performance.

Novato, CA

QA Operations Specialist

• Support the development, implementation, maintenance and improvement of the document control system in accordance with FDA, EMA, and other regulatory agency requirements, ensuring that all quality documents are properly and efficiently managed and accessible.
• Support the maintenance of QADC hours for Logbooks, corrections, and archive access during business hours with additional hours as needed during audits and inspections.
• Ensure all quality documents are properly managed, accessible, and adhere to Good Documentation Practices (GDP).
• Support the management of the lifecycle of quality documents, including archiving and retrieval processes.
• Support the maintenance of multiple databases such as Logbook trackers, scanned logbooks, notebook trackers, and offsite storage.

• BA/BS in life sciences or related field
• Advance degree desirable but not required.
• Minimum of 3 years within the biotechnology or pharmaceutical industry.
• Extensive knowledge of GMP, FDA, EMA, and other regulatory requirements.
• Proficient in Veeva EDMS.

• Medical insurance – PPO, HMO &
• Dental & Vision insurance
• 401k plan
• Employee Assistance Program
• Long-term disability
• Weekly payroll
• Expense reimbursement
• Online timecard approval

Ready to make an impact? 🚀 Apply now and let’s grow together!