Validation Coordinator at LifeSouth Community Blood Centers

Gainesville, Florida, United States -

Full Time

Start Date

Immediate

Expiry Date

10 Feb, 26

Salary

60500.0

Posted On

12 Nov, 25

Experience

2 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Detail-Oriented, Laboratory Validation, Quality Assurance, Regulatory Compliance, Analytical Skills, Organizational Skills, Communication Skills, Documentation, Report Writing, Project Management, Test Method Validations, Calibration, Preventive Maintenance, Training, Cross-Functional Collaboration, Industry Trends

Industry

Hospitals and Health Care

Description

Description 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. Our Benefits - 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 Key Responsibilities - 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. Qualifications - Bachelor’s degree in Medical Technology, Life Sciences, Engineering, or related field required. - Strong analytical, organizational, and communication skills. - Certification as a Medical Laboratory Scientist (MLS) or equivalent preferred. - Proficiency in documentation and report writing. - Ability to manage multiple projects and meet deadlines. Preferred Skills/Qualifications - 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. Who We Are LifeSouth is a non-profit community blood bank serving more than 150 hospitals in Alabama, Florida, Georgia and Tennessee. We are committed to meeting the blood supply needs of hospitals and their patients by providing the highest quality blood components and services. With more than 45 donor centers, 55 bloodmobiles and 2,000 blood drives a month, our LifeSouth team is dedicated to making sure the blood is there when you or your family is in need. Our Mission To provide a safe blood supply that meets or exceeds the needs in each community we serve, and to provide a variety of services in support of ongoing and emerging blood and transfusion related activities. This is a full-time position. Starting salary range is $55,000 - $60,500 per year. Criminal background check and drug screen required upon conditional offer of hire. Equal Opportunity/Affirmative Action Employer/Drug-Free/Tobacco Free Workplace. The position description may not include all the duties and responsibilities of the job. Duties and responsibilities that are not listed, but which the employee may be expected to perform, will fall within the scope of the skills, knowledge and training for the position. LifeSouth is a Drug-Free and Tobacco-Free Workplace. LifeSouth is a VEVRAA Federal Contractor as well as an affirmative action employer and provides equal opportunity to all persons, regardless of race, religion, age, gender, disability, status as a protected veteran, national origin, color, or any other classification in accordance with federal, state, and local statutes, regulations, and ordinances. Veterans are encouraged to self-identify as LifeSouth desires to provide protected veterans priority referrals for open positions. LifeSouth complies with all laws and regulations associated with the Family Medical Leave Act (FMLA) and the Americans with Disability Act (ADA). LifeSouth is an E-Verify employer. If you require any assistance to complete the application process or during the interview due to a disability, please contact the LifeSouth region where you are applying or call 1-888-795-2707 to request an accommodation. Applications may be completed at a LifeSouth facility or mailed to corporate headquarters in lieu of the on-line application process.

Responsibilities

The Validation Coordinator will develop, execute, and maintain validation protocols for blood bank equipment and processes. This role also involves ensuring compliance with regulatory standards and collaborating with cross-functional teams to support validation efforts.