Quality Systems Specialist - Exagen Inc.

Exagen is a patient-focused and discovery-driven life sciences company dedicated to transforming the care continuum for patients suffering from debilitating and chronic autoimmune diseases. Our goal is to enable rheumatologists to improve care for patients through the differential diagnosis, prognosis, and monitoring of complex autoimmune and autoimmune-related diseases, including lupus and rheumatoid arthritis. By leveraging our proprietary Cell-Bound Complement Activation Products, or CB-CAPs, technology, we help get to the real cause of a patient’s symptoms and guide their journey to improved health.

Under the supervision of the Quality Systems Manager, the Quality Specialist will support company-wide initiatives to maintain the highest standards of quality care and ensure adherence to regulatory requirements.

Note: Other duties may be assigned.

• Respond to Document Control related activities throughout the site.
• Manage training documentation and track employee compliance with training plans.
• Monitor and audit processes to ensure compliance with quality standards and regulations.
• Manage vendor Qualification program, including overseeing vendor approval and maintaining an up-to-date list of approved vendors.
• Manage equipment calibration and preventive maintenance programs, maintaining the equipment master list.
• Work with the QA (quality assurance) manager to resolve issues associated with complaints and deviations.
• Perform other duties as assigned or requested.

Minimum Qualifications:

• Minimum of a bachelor’s degree in biology, chemistry, or other related sciences.
• Experience following laboratory procedures and systems regulated environment.
• Working knowledge of state/local regulations, CAP/CLIA, IVDR, OHS/OSHA, FDA/ISO regulations, New York State clinical lab guidelines, and GLP/GDP standards.
• Highly organized and able to demonstrate independence and a strong work ethic to execute multiple assignments with tight deadlines under minimal supervision.
• Able to work both independently and collaboratively with other departments & shareholders
• Detail-oriented, with strong written and verbal communication skills.

Preferred Qualifications:

• Experience in MediaLab is a plus.

Pay range: $25.95/hr - $38.80/hr