Under the direction of the department, Manager, provides consultative expertise and support to Blood Services operational departments to achieve process control, process improvement, customer satisfaction, and overall operational effectiveness/quality with respect to compliance with regulations, safety, and quality measurements of operations.
MAJOR RESPONSIBILITIES*Facilitates the development of organizational quality for all Blood Services operational departments
*Works with departmental staff/management to review and verify correctness and ease of use of departmental QSDs which are compliant with regulations, policies, and pertinent quality performance expectations.
*Facilitates the department(s) ability to recommend process changes as a result of process analysis.
*Consults with operational units to lead and oversee efficient change control and validation processes.
*Works directly with the operational units to collect, organize, monitor, and distribute any information related to the quality functions within the departments.
*Oversees and Assists the departments in tracking audit, proficiency testing, and incident management results/ responses, makes recommendations for improvements/corrective action/retraining,
*Prepares monthly reports.
*Performs impact assessments and determines product suitability resulting from incident management events.
* monitors the effectiveness of corrective action; coordinates follow-up and participates in system design and implementation to ensure process control.
*Serves as a resource person for procedural and regulatory issues for the department.
*Participates in external and internal audits.
*Reviews operational records on a daily, monthly, and quarterly basis as needed and supports lot release functions
*Manages all research protocols associated with collecting and testing of blood products
*Acts as project lead for organizational/department changes
GENERAL DUTIES*Assists in the achievement of departmental goals and objectives in support of the vision and mission of Versiti.
*Maintains up-to-date knowledge of quality issues through participation in meetings, task forces, committees and self-directed learning.
*Upholds and reinforces the customer service standards of Versiti.
*Participates in creation and delivery of training on a process level.
*Acts as a partner with the other members of the departments to provide services to customers.
*Performs other duties as assigned.
NOTE: The above is intended to describe the general content of and requirements for the performance of this job. It is not to be construed as an exhaustive statement of duties, responsibilities or requirements.
EXPERIENCE
*2+ years technical or managerial experience in a regulated industry where change management validation and creation of SOPs (standard operation procedures) or QSDs have been required and successfully completed
*Manufacturing experience in a cGMP, ISO (International Organization for Standardization), or equivalent certified environment is preferred
*One to three years technical writing experience preferred
*Experience in educational development programs that delivered technical content is preferred
EDUCATION
*Bachelor's degree in Medical Technology or field related to blood center activities
SKILLS AND KNOWLEDGE
*Strong organizational skills with excellent verbal and written communication skills
*Proven problem solving skills
*Excellent leadership and coaching skills
*Knowledge of the principles of adult learning techniques and effective training abilities
*Demonstrated technical writing skills to write validation plans
*Ability to read, interpret, and functionally apply federal, state, and accrediting agency regulations
*Ability to ensure QSDs (quality system documents) are compliant with regulations, policies, and pertinent quality performance expectations
*Ability to facilitate departments in analyzing processes, applying applicable regulations, and recommending process changes
*Ability to facilitate departments' validation processes
*Knowledge of root cause analysis techniques for tracking and trending and statistical analysis
*Ability to analyze information from control and tracking systems and make recommendations for improvements and corrective actions
*Ability to review audit, incident report, and proficiency testing results to determine necessary training and corrective action
*Computer skills including word processing, electronic spreadsheets, and other database software programs
*Working knowledge of quality business processes such as current Good Manufacturing Practices (cGMPs) and Continuous Quality Improvement (CQI)
EQUIPMENT USED
*Computer software including word processing, spreadsheets, databases, statistical analysis tools
PHYSICAL/MENTAL STRESS FACTORS
*Overall sedentary position
*Mental stress within limits anticipated due to the scope of the position
Equal Opportunity Employer. This company will provide equal opportunity to all individuals without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or veteran status.
