Onsite Quality Systems Manager

Posted 4 hours ago

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About the role

  • Quality Systems Manager ensuring compliance and quality improvement at plasma donor center. Leading audits and training to maintain the highest standards in healthcare.

Responsibilities

  • Evaluates processes, develops action plans, and coordinates the strategic implementation of quality system processes
  • Maintains oversight of the center’s quality management system
  • Directs and monitors processes and ensures center compliance with all applicable state, federal, and company-designated regulations
  • Maintains oversight of center training program by ensuring compliance to program requirements
  • Collaborates with Center Manager to ensure the donor center operates in a manner which assures product quality
  • Responsible for the personnel functions of the Quality Systems Associate
  • Responsible for oversight of all aspects of internal and external audits
  • Continuously assesses, promotes, and improves the effectiveness of quality and training systems in the donor center
  • Documents, investigates, and performs root-cause analysis for deviations and customer complaints
  • Investigates identified trends and performs follow-up on corrective and preventative actions
  • Oversees product and biohazard waste shipments
  • Performs a review of the documentation of unsuitable test results
  • Performs a review of donor adverse event reports
  • Ensures that job and center annual training is completed
  • Performs employee training observations to ensure staff competency
  • Ensures that all supplies and materials ordered meet quality requirements
  • Determines donor suitability activities and manages donor deferrals as appropriate
  • Prepares quality analysis reports to track issues and set goals
  • Ensures that Clinical Laboratory Improvement Amendments (CLIA) proficiency test surveys, complaint investigations, and training have been properly documented
  • Holds monthly Quality Meeting to communicate status updates and manage action outcomes

Requirements

  • Bachelor of Science degree or equivalent
  • Typically requires 2 years of related experience in a medical and/or cGMP regulated environment

Benefits

  • medical
  • PTO
  • up to 5% 401K match
  • tuition reimbursement

Job title

Quality Systems Manager

Job type

Experience level

JuniorMid level

Salary

Not specified

Degree requirement

Bachelor's Degree

Location requirements

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