Quality Assurance Manager Jobs

Job Title: Quality Assurance Manager

Reports To: Corporate Director, QA Direct

Report Status: This position has direct reports.

Company Overview

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.

Purpose and Role

This position is responsible for the oversight and compliance to the quality program at the Olgam Plasma Center location. The Quality Assurance Manager 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. In alliance with Center Operations, manages and maintains a state 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. Responsible for reporting any deviation of federal, local, or organizational operating procedures.
4. Responsible for tracking and trending errors, assessing risk, corrective actions related to deviations, and approval of preventative actions.
5. Authorizes the release, quarantine hold, or investigation of all collected product.
6. Responsible for training and the development of all center quality roles.
7. Routinely reports center compliance status to operational management.
8. Oversees/hosts, reviews, and responds to both internal and external audits
9. Provides continuous feedback to center personnel in performance related to compliance and regulatory standards.
10. Delegates quality assurance program duties the Quality Assurance Associate(s) as appropriate.
11. Other duties as assigned by Quality Leadership.

Requirements

• Good verbal and written communication skills
• Scheduling flexibility to ensure appropriate center support and coverage
• Must be able to work independently with minimal direct oversight
• Professional communication and the ability to inform and report appropriately to executive leadership
• B.S./B.A degree required. Also, acceptable educational requirements include Degree or Certificate in Business Management or Organizational development. Education may be substituted for experience as described below.
• Ability to execute multi-step technical driven tasks
• A minimum of 2 years’ experience as a people manager is required
• A minimum of 2 years’ experience working in a regulated environment is preferred
• An ASQ related certification such as CQIA or CQPA is preferred
• Organizational skills and attention to detail
• Familiarization with electronic systems/platforms used to organize, track, and execute tasks
• Able to evaluate and interpret regulations and recognize the need for appropriate changes relative to business operations
• Ability to travel up 25% as needed

Education

B.S./B.A degree required.

A high school diploma or equivalent is required.