QAA

Purpose and Role

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.

Job Duties and Responsibilities

1. Through direction provided by the Quality Assurance Manager, supports the management and maintenance of compliance ensuring the center remains audit ready.

2. 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.

3. Reports any deviation of federal, local, or organizational operating procedures.

4. Tracks and trends errors, assessing risk, corrective actions related to deviations, and approval of preventative actions.

5. May authorize the release, quarantine hold, or investigation of all collected product under the direction of the Quality Assurance Manager.

6. Reports center compliance status to the Quality Assurance Manager.

7. Oversees/hosts, reviews, and responds to both internal and external audits

8. Provides continuous feedback to center personnel in performance related to compliance and regulatory standards.

9. Other duties as assigned by Quality Assurance Manager.

Requirements

B.S./B.A degree preferred. Also, acceptable educational requirements include Degree or Certificate in Business Management or Organizational development.  Education may be substituted for experience as described below. 

A minimum of 1 years' experience working in a regulated environment is preferred

Must be able to work independently with minimal direct oversight

Able to evaluate and interpret regulations and recognize the need for appropriate changes relative to business operations

Organizational skills and attention to detail

Good verbal and written communication skills

Professional communication and the ability to inform and report appropriately to executive leadership

Scheduling flexibility to ensure appropriate center support and coverage

Ability to execute multi-step technical driven tasks

Familiarization with electronic systems/platforms used to organize, track, and execute tasks

Ability to travel up 25% as needed

Ability to sit, stand, and/or walk for a minimum of 8 hours in a scheduled work day.

Education

B.S./B.A degree preferred.

A high school diploma or equivalent is required.