Job Description

Manages the day-to-day activities of a functional area within the Quality Assurance Regulatory Affairs department. Facilitates the interpretation and implementation of quality and regulatory requirements to ensure compliance. Coordinates regulatory affairs activities to ensure appropriate filing and registration activities are complete. Serves as a resource person for departments in accordance with regulatory agency requirements and organizational policies and procedures.

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.

• Manages the operations of a functional area within Quality Assurance and Regulatory Affairs ensuring efficiency of workflow and continuity of services
• Ensures compliance with organization, federal, state and local regulations, AABB standards and others
• Hosts external assessments and inspections conducted by agencies with regulatory or accreditation authority and helps prepare appropriate responses when indicated
• Maintains internal audit program to include root cause analysis, corrective and preventative action
• Facilitates and monitors change control, taking appropriate actions to ensure uninterrupted compliance and quality
• Oversees document control system and ensures organization documents, forms and records are relevant, current and archived appropriately
• Assists with the development of validation plans for equipment, software and processes; reviewing, editing and approving protocols before use
• Manages the error management program and completes required notifications as indicated
• Manages Biovigilence activities which includes but is not limited to donor notifications, Suspected Transfusion Disease investigations, Inventory and Donor lookbacks, and duplicate donor resolutions
• Participates in or initiates process improvement activities.

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:

Bachelor's degree in medical technology, healthcare, chemistry, biology, biotechnology or related field from an accredited college or university. Five (5) or more years experience in a related field with at least two (2) years management supervisory experience or an equivalent combination of education, certification, training, and/or experience.

CERTIFICATES, LICENSES, REGISTRATIONS AND DESIGNATIONS:

Valid and current Florida Technologist license in Immunohematology preferred. ASQ certification preferred.

KNOWLEDGE, SKILLS AND ABILITIES:

• Knowledge of and ability to interpret and apply federal and state regulations as they relate to quality assurance and regulatory affairs
• Ability to organize work for timely completion
• Ability to follow complex oral and written instructions
• Ability to communicate effectively orally and in writing
• Ability to delegate, manage and supervise effectively
• Ability to work with minimal supervision
• Ability to establish and maintain effective and cooperative working relationships with those contacted in the course of work
• Skill in operating office equipment
• Ability to travel 20% of the time
• Basic computer knowledge including Microsoft Office applications
• Ability 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).

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