Independent Contractor - Quality Assurance Specialist
San Diego, CA
Part-Time- (5 Hours a week)- ON SITE VISITS REQUIRED, MUST BE LOCATED IN SAN DIEGO
Sanguine Biosciences is accelerating personalized medicine research by empowering patients with their healthcare data and making it as easy as possible for them to participate in the medical research process. We partner with patients and pharmaceutical companies to accelerate precision medicine R&D by securely and efficiently collecting and providing patient samples and relevant health data. We are helping thousands of researchers at 20 of the top 40 global pharmaceutical and biotechnology companies increase the speed and quality at which they are conducting their research. For the past three years, Sanguine received the prestigious designation as a “Great Places to Work” company. It is an exciting time; our biotech company is growing quickly and needs the best team members to join us.
About the Role:
The Quality Assurance Specialist is responsible, under Director level supervision, for leading, supporting, and ensuring continued suitability of the Quality Management System (QMS) with a primary focus on internal auditing, and lab process compliance review.
- Conduct supplier audits and host or co-host client audits.
- Support the annual audit program; manage, schedule, perform and report on internal, external and supplier audit activity.
- Conduct monthly lab audits and review lab processing workflows/paperwork for compliance to SOPs.
- Bachelor's Degree in Biology, Chemistry, Life Sciences or Engineering, required
- At least 5 years of experience in a quality role supporting clinical research, or pharmaceutical development. Note: An advanced degree in Biology, Chemistry or Life Sciences may be accepted in lieu of some professional experience.
- Regulatory Certifications such as ASQ / SQA certification and Six Sigma Black Belt preferred.
- Membership (national or local chapters) to SQA demonstrating Continuing Education
- Strong computer literacy skills.
- Excellent oral and written communication.
- Strong organization and time management is required.
- Proficient verbal communication skills are required.
- Autonomy and independence preferred.
Sanguine is an equal opportunity workplace. We are committed to equal employment opportunity regardless of race, color, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, disability, gender identity or Veteran status.