Validation Coordinator

LifeSouth Community Blood Centers-posted about 1 month ago
$55,000 - $60,500/Yr
Full-time • Mid Level
Onsite • Gainesville, FL
501-1,000 employees
Ambulatory Health Care Services
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Are you looking to make a difference in your community and help save lives? Seeking to work for a non-profit whose values include safety, teamwork, and stewardship? Do you have a passion for leading others? We are seeking a detail-oriented and experienced Validation Coordinator to oversee validation activities within our blood bank operations. This role operates out of our Gainesville, FL office and is responsible for ensuring that all equipment, processes, and systems comply with regulatory standards including FDA, AABB, and cGMP guidelines. The ideal candidate will have a strong background in laboratory validation, quality assurance, and regulatory compliance, with specific experience in developing and executing new test method validations.

  • Develop, execute, and maintain validation protocols (IQ/OQ/PQ) for blood bank equipment and processes.
  • Write implementation plans and protocols for new test method validations, ensuring accuracy, reproducibility, and regulatory compliance.
  • Coordinate and document validation activities including calibration, requalification, and preventive maintenance.
  • Ensure compliance with federal, state, and local regulations, including FDA and AABB standards.
  • Collaborate with cross-functional teams including QA, lab operations, and IT to support validation efforts.
  • Maintain accurate records of validation activities and generate comprehensive reports.
  • Stay current with industry trends, regulatory updates, and best practices in blood banking and validation.
  • Train staff on validation procedures and compliance requirements.
  • Bachelor's degree in Medical Technology, Life Sciences, Engineering, or related field required.
  • Strong analytical, organizational, and communication skills.
  • Proficiency in documentation and report writing.
  • Ability to manage multiple projects and meet deadlines.
  • Experience with electronic documentation systems.
  • Minimum 3 years of experience within a regulated healthcare or laboratory environment.
  • Familiarity with blood bank operations and/or regulatory (FDA, AABB, CLIA).
  • Hands-on experience with laboratory testing methodologies and/or blood banking.
  • Certification as a Medical Laboratory Scientist (MLS) or equivalent preferred.
  • Generous Paid Time Off (PTO)
  • Medical, dental, and vision insurances available to full-time employees the first of the month after 60 days
  • Supplemental insurances including life, cancer, accident, and disability
  • Access to mental wellness resources and counseling through telehealth
  • Free basic life insurance for full-time employees
  • Health Savings Account (HSA) with employer match each pay period
  • Employer funded retirement plan for vested employees & 403b offered
  • Access to wages prior to pay day
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