Manager Quality Assurance

OneBlood•Charlotte, NC

7d•Onsite

About The Position

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.

Requirements

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.
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.

Nice To Haves

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

Responsibilities

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.