Overview:Performs quality assurance and regulatory work. Conducts audits, validations and process review for regulated departments within the organization and prepares written reports of any deficiencies. Completes documents required for compliance and regulatory submissions. Participates in inspections and provides regulatory guidance to staff. Team members who will work from St Petersburg, Jacksonville or Tallahassee hubs are preferred for this position. Responsibilities:The list of essential functions, as outlined herein, is intended to be representative of the duties and responsibilities performed within this classification. It is not necessarily descriptive of any one position in the class. The omission of an essential function does not preclude management from assigning duties not listed herein if such functions are a logical assignment to the position.Performs quality assurance and regulatory work in accordance with organizational SOP and regulatory standardsConducts audits and reviews of processes and procedures for compliancePrepares written reports based on trends from inspection/audit findings and initiates corrective actionsAssists in the development and implementation of new procedures and regulatory requirementsCompletes documents required for compliance and regulatory submissionsParticipates in regulatory and accrediting inspections, organizing pre-inspection documents, preparing reports and maintaining records. Qualifications:To perform this job successfully, an individual must be able to perform each essential duty and responsibility satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required.EDUCATION AND/OR EXPERIENCE:Associates Degree in biological science or related field and three (3) years experience in blood bank setting; or an equivalent combination of education, certification, training, and/or experience. Prior experience with blood bank systems requirements and procedures preferred.CERTIFICATES, LICENSES, REGISTRATIONS AND DESIGNATIONS:NoneKNOWLEDGE, SKILLS AND ABILITIES:Knowledge of and ability to interpret and apply federal, state and accrediting agency regulationsAbility to formulate, initiate, and administer policies and procedures for effective fiscal controlAbility to organize work for timely completionAbility to follow complex oral and written instructionsAbility to communicate effectively orally and in writingAbility to work with minimal supervisionAbility to establish and maintain effective and cooperative working relationships with those contacted in the course of workSkill in operating office equipmentBasic computer knowledge including Microsoft Office applicationsAbility to travel up to 50% of the timeAbility to commute with personal transportation.PHYSICAL REQUIREMENTS:The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Ability to exert light physical effort in sedentary to light work, which may involve some lifting, carrying, pushing and/or pulling of objects and materials of light weight (up to 20 pounds). May involve some climbing, balancing, stooping, kneeling, crouching, crawling, walking or standing.ENVIRONMENTAL REQUIREMENTS:The work environment characteristics described here are representative of those an employee may encounter while performing the essential functions of this job.Functions are regularly performed inside without potential for exposure to adverse conditions, such as inclement weather, atmospheric elements and pathogenic substances. The noise level in the work environment is usually moderate.OneBlood is an Equal Opportunity Employer/Vet/Disability/Other Protected Categories
