Quality Assurance Associate

Olgam Life•New York, NY

3d•$20 - $24•Onsite

About The Position

Olgam Life is a plasma donation service offering state-of-the-art treatment of donors while providing life-saving resources for the medical industry. Our commitment to the highest standards is absolute, from the time the client walks in the door to the moment the plasma leaves our facility. Olgam Life focuses solely on the aggregation aspect of the donation process, enabling us to focus more closely on the care our donors receive. This position is responsible for supporting the oversight and compliance to the quality program at the Olgam Plasma Center location. The Quality Assurance Associate will ensure each center process adheres to all federal, local, and organizational standards related to the collection and manufacturing of human blood plasma.

Requirements

Support of oversight and compliance to the quality program.
Ensure adherence to all federal, local, and organizational standards related to the collection and manufacturing of human blood plasma.
Report deviations of federal, local, or organizational operating procedures.
Track and trend errors, assess risk, and manage corrective and preventative actions.
Authorize release, quarantine hold, or investigation of collected product under direction.
Report center compliance status.
Oversee/host, review, and respond to internal and external audits.
Provide continuous feedback to center personnel on compliance and regulatory standards.

Responsibilities

Supports the management and maintenance of compliance ensuring the center remains audit ready.
Oversees the compliance and regulatory adherence of all center processes including but not limited to, production flow, facility maintenance, equipment maintenance, supply and inventory management, employee relations, customer complaints, compliance and regulatory programs, training programs, product management, and medical management.
Reports any deviation of federal, local, or organizational operating procedures.
Tracks and trends errors, assessing risk, corrective actions related to deviations, and approval of preventative actions.
May authorize the release, quarantine hold, or investigation of all collected product under the direction of the Quality Assurance Manager.
Reports center compliance status to the Quality Assurance Manager.
Oversees/hosts, reviews, and responds to both internal and external audits.
Provides continuous feedback to center personnel in performance related to compliance and regulatory standards.
Other duties as assigned by Quality Assurance Manager.