R&D Partners is seeking to hire a QA Operations Specialist in Novato, CA.
Your main responsibilities as a 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.
What we are looking for in a QA Operations Specialist:
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.
Why Choose R&D Partners?
As an employee, you have access to a comprehensive benefits package including:
Pay Scale:
$66,443 $83,054 Dependent on Experience)
R&D Partners is a global functional service provider and strategic staffing resource specializing in scientific, clinical research & engineering. We provide job opportunities within major pharmaceutical, biopharmaceutical, biotechnology, and medical device companies.
R&D Partners is an equal-opportunity employer.