Quality Systems Analyst Plasma Donation Center

About the role

This position is responsible for supporting the oversight and compliance to the quality program at each of the assigned Olgam Plasma Center locations. The Quality Assurance Data Analyst will ensure each assigned center process adheres to all federal, local, and organizational standards related to collecting and manufacturing human blood plasma.

Responsibilities

• Supports the maintenance of compliance through reviewing relevant systems, ensuring Olgam Life Centers remains audit ready.
• Reports any deviation of federal, local, or organizational operating procedures to the Manager, Quality Systems Analyst, and Center QA personnel.
• Reports center compliance issues to the Manager, Quality Systems Analyst, and Center QA personnel.
• May provide coverage for Center QA as needed to include: the authorization of release, quarantine hold, or investigation of all collected product, and providing support for overseeing/hosting, reviewing, and responding to internal and external audits.
• Under the direction of the Manager, the Quality Systems Analyst is responsible for entering donors into the National Donor Deferral Registry.
• Comply with all Health Safety and Environmental (HSE) and Occupational Safety and Health Administration (OSHA), federal, state, and local regulatory, company policies and procedures.
• Follow all HR policies and practices through fair treatment of all employees.

Requirements

• B.S./B.A. degree is preferred.
• Also, acceptable educational requirements include a Degree or Certificate in Business Management or Organizational development.
• Education may be substituted for experience, as described below.
• A minimum of 1-year experience working in a regulated environment is preferred.
• Must be able to work independently with minimal direct oversight.

Qualifications

• A high school diploma or equivalent is required.