Donor Quality Assurance Analyst

Ensure that all donors accepted and processed at CryoLife are properly identified, controlled, and meet all required quality specifications and regulatory standards prior to release for distribution. Ensure that all areas outlined under “Principal Responsibilities” are accomplished in an efficient, professional manner. May function as a primary Region Contact facilitating all donor charts within the assigned region, front facing DQA contact with Recovery Partners holding conference calls or other online meetings as necessary to resolve any partner concerns.

• Provide support to Account Managers and facilitate obtaining donor chart information to accurately complete donor chart reviews.
• Organize donor chart information and all charting follow-up to meet required chart review targets and workflow.
• Maintain accurate pending chart information lists and pending additional information.
• Ensure donors received for processing are properly identified, controlled, and meet required quality specifications and regulatory standards prior to release.
• Perform the quality review of donor records prior to Final Review and Medical Directors review for donor eligibility.
• Timely evaluation and disposition of issues concerning nonconforming donors.
• Develop systematic methods for completing work assignments to ensure timelines are met and personal job commitments are accomplished.
• Understand ISO requirements, AATB, GTPs, and the Quality System Regulations as they pertain to the entire operation, i.e., nonconformities, Good Documentation Practices, calibration, equipment maintenance, product storage and identification, etc.
• Ensure that donors with status of Pending Complete and Pending Reject are properly identified, controlled, and meet the required quality specifications for discard prior to chart completion.
• Provide input to management that facilitates the process for new, revised, and obsoleted documents (policies, procedures, forms, templates, etc.) as they pertain to the job.
• Provide mentoring and assistance to DQA Technicians.
• Ability to lead and present ideas that are motivating, by maintaining positive support, setting a positive example, and establishing an overall objective and creative atmosphere.
• Increase productivity and revenues by optimizing processes and workflows.
• Effectively complete “other” functions that may be assigned.

Qualifications

  • Bachelor’s Degree in the Life Sciences or other scientific field or equivalent work experience.
  • Certified Tissue Bank Specialist (CTBS) certification preferred.
  • Minimum 1 year experience in Quality preferred.
  • Previous experience in a regulated industry is preferred.
Equal Opportunity Employer/Protected Veterans/Individuals with Disabilities

Company
CryoLife Inc.
Posted
10/06/2021
Type
Full time
Salary Range
$56,000.00 - 79,000.00
per Year
Salary range estimated by
Location
Kennesaw, GA 30144, US
Apply Now