Versiti is a fusion of donors, scientific curiosity, and precision medicine that recognize the gifts of blood and life are precious. We are home to the world-renowned Blood Research Institute, we enable life saving gifts from our donors, and provide the science behind the medicine through our diagnostic laboratories. Versiti brings together outstanding minds with unparalleled experience in transfusion medicine, transplantation, stem cells and cellular therapies, oncology and genomics, diagnostic lab services, and medical and scientific expertise. This combination of skill and knowledge results in improved patient outcomes, higher quality services and reduced cost of care for hospitals, blood centers, hospital systems, research and educational institutions, and other health care providers. At Versiti, we are passionate about improving the lives of patients and helping our healthcare partners thrive.

PURPOSE: Responsible for organizing, developing, executing and revising processes, procedures, job aids, forms, validations and other change control documents as needed FUNCTION: Develops validation and qualification protocols of new and existing equipments, performs and coordinates validations of testing equipment/reagents. Responsible for the development and revision of a majority of all departmental SOP's. Ensures training on new equipment or new/revised procedures is performed in a timely manner by the assigned individual. Initiates change controls, impact assessments and works closely with Director and Laboratory Supervisors to ensure timely and accurate validations. Provides technical support to the Testing Department to ensure efficient and effective testing services. ALLOCATION OF TIME: This position can spend up to 50% of their time developing validation plans, summarizing validation results, and generating validation reports; 45% of the time this position may write, revise, or reformat departmental SOP's; the remainder of time may be spent performing training on new equipment or procedures.

Benefits
Versiti provides a comprehensive benefits package based on your job classification. Full-time regular employes are eligible for Medical, Dental, and Vision Plans, Paid Time Off (PTO) and Holidays, Short- and Long-term disability, life insurance, 7% match dollar for dollar 401(k), voluntary programs, discount programs, others.

• Manages and ensures that the validation/qualification of new equipment, software or methodologies is accomplished through the following steps: development of a validation/qualification plan, execution of plan, review, approval, compilation and summary of validation data, and the development of SOP’s and training materials for use during and after validation.
• Creates new SOP’s and revises existing SOP’s
• Assists in the coordination of special projects/clinical trials as directed by the Director of Testing. Works closely with QA to ensure that all supporting documents pertaining to validation/qualifications are approved prior to and after the execution and before going live.
• Participates in the training of new and existing staff as needed.
• Assists in the development and/or implementation of corrective actions that may involve departmental form or SOP reformatting. Keeps track of revisions that need to be made in accordance with a planned corrective action.
• Maintains and updates the departmental equipment list.
• Helps to coordinate cross-departmental projects lead by the Testing Laboratory.
• Conducts internal departmental audits to ensure compliance to SOP’s and other policies.
• Participates in professional activities and continuing education opportunities to maintain technical expertise in improvement processes and systems. Attends meetings inside and outside the blood center as required and as directed.
• Maintains knowledge of regulatory requirements and standards including FDA current Good Manufacturing Practices.
• Complies with all IBC safety policies and procedures.
• Follows universal precautions and protective measures required by IBC and outside regulatory agencies. Incumbent may be exposed to blood or body fluids or be in areas which contain these items.
• Performs other duties as assigned. May be delegated to be Safety Officer of Testing Laboratory
• Performs other duties as assigned
• Complies with all policies and standards

Education

• Associate's Degree in biology or a related science field and certification as a Medical Laboratory Technician (MLT-ASCP) required
• Bachelor's Degree in biology or a related field and certification as a Medical Technologist (MT-ASCP) preferred

Experience

• 1-3 years One (1) to Three (3) years Laboratory testing experience, exposure to QC principles, and validation experience required
• Donor testing experience preferred
• Refer to training programs for applicable standard operating procedures and training checklists, including but not limited to those standard operating procedures in the Testing Laboratory, Quality Assurance and Safety series. required

Knowledge, Skills and Abilities

• The Testing Lab Projects and Validations Coordinators must be able to express him/herself clearly and effectively in oral and written form.
• They must be able to communicate effectively with co-workers, management, and vendors as necessary.
• He or she must be proficient in technical writing and interpersonal skills.
• The Projects and Validations Coordinator must have the ability to coordinate the use of necessary laboratory or instrument software and hardware to accomplish functions of the position.
• Must be computer literate and able to utilize the necessary software and hardware to perform the functions of the job and access company communications.
• The Projects and Validations Coordinator must be able to: • work efficiently under pressure and time constraints; • manage multiple tasks or projects simultaneously; • communicate with people of diverse cultures and/or educational backgrounds; • work hours other than those primarily designated to support the department; and • demonstrate independent decision making.