Quality Assurance and Training Coordinator 

Summary:  

This position is responsible for performing quality assurance and training activities in the Whole Blood center as defined in Standard Operating Procedures. The responsibilities include, but are not limited to, reviewing records, monitoring employee practices, assessing processes for compliance to procedures, evaluating corrective and preventive action for effectivity, and notifying management and Corporate Quality Assurance of quality concerns related to practices and/or product. This position is also responsible for the coordination, implementation, and monitoring of all training initiatives for Whole Blood center personnel. 

Primary Responsibilities: 

• Independent level of quality inspection and control -- ensures center compliance with quality standards and regulations by collaborating with Center Manager and Regional Quality Manager to ensure product quality, donor suitability and donor safety.                                                                    

• Directs and monitors processes and ensures center compliance with all applicable state, federal, and company-designated regulations while ensuring that Standard Operating Procedures (SOPs) are properly interpreted, implemented in a timely fashion, and that the staff performs according to all SOPs.     

• Interprets and implements processes, regulations and SOPs for quality control and overall regulatory compliance, making independent decisions and modifications as required.                                              

• In coordination with Center Manager and Regional Quality Manager, oversight of all aspects of internal and external audits including execution (if applicable).  This includes documentation, review of and preparation of the response. Also including implementation of corrective and preventative action, assessment of corrective and preventative actions and follow-up as required.                                                       

• Continuously assesses, promotes, and improves the effectiveness of the quality systems in the donor center through recognition of trends, investigation of failures in the execution of procedures, direct employee observation and review of center documents.                                                              

• Responsible for the personnel functions of the Training Monitor(s); including direction, assignment of work, development and training.                                                                   

• Oversees product and biohazard waste shipments:  Ensures shipments meet regulatory specifications and product release requirements; ensures accurate labeling and documentation; and, authorizes final shipment.                                                               

• Performs a review of all test results and verifies that all unsuitable donors are properly documented            

• Works in collaboration with the Center Manager to develop the staff’s knowledge of their job function and how their performance relates to the end product and patient.                                                                      

• Documents, investigates, and performs root cause analysis for deviations and customer complaints, specifically in how they relate to the safety of the donor and the quality of the product.                                                                     

Additional Responsibilities:        

• Documents and tracks/trends center quality incidents and follows-up on incidents/errors as required; reports critical incidents and problematic trends to Center Manager. 

• Reports compliance status to necessary parties. 

• Reviews SOP’s with trainees and performs job skills during training. 

• Ensures accuracy of donor files. 

• Ensures that all supplies and materials ordered meet quality requirements prior to use and are stored in appropriate temperature/facility conditions at all times.   

• Initiates appropriate investigations if these requirements are not met.  Initiates rejection of supplies for non-conformance. 

• Directs the maintenance and calibration of equipment and documentation of procedures. 

• Monitors training documents to ensure compliance with all applicable policies and procedures. 

• Ensures that job and Current Good Manufacturing Practice (cGMP) training is completed, documented, and on file. 

• Tracks/Trends and performs follow-up on corrective and preventative actions, system implementations, and process improvement plans to measure/determine effectiveness. Makes adjustments where required. 

• Ensures that quality control (QC) checks are performed as required and are in acceptable ranges for test reagents. 

• Directs routine verification of the SOP and forms to ensure that they are up to date in the Donor Center’s manual. 

• Partners with the Center Manager to determine donor suitability activities and manages donor deferrals as appropriate. 

• Prepares quality analysis reports to track issues and set goals. Does in depth research and analysis to resolve systemic compliance issues. 

• Builds rapport with donors to ensure overall customer satisfaction with the Center to support long-term donation. 

• Reviews and approves of deferred donor reinstatement activities. 

• Performs a review of lookback information. 

• Performs a review of medical incident reports and the applicable related documentation.                                                              

Knowledge, Skills, Abilities:  

• Command of interpersonal communication, organizational and problem-solving abilities.  

• Ability to understand and assess FDA regulations.   

• Strong integrity and commitment to quality and compliance.  

• Full command of mathematics.   

• Legible handwriting.   

• High level of proficiency with computers. 

• Proficient in root cause analysis and corrective/preventative actions.   

• Ability to balance multiple competing priorities.   

• Strong time management abilities.   

• Proven ability to maintain a high level of quality and compliance and to become a valuable member of the center leadership team.   

• Ability to work with minimal supervision.   

• Ability to travel when needed for meetings, events, and occasional support of other centers. 

Education:  

• Bachelor of Arts or Bachelor of Science degree preferred.   

• Certified and proficient as a Designated Trainer or commitment to complete a certification program as a reimbursable educational expense covered within the Grifols Tuition Reimbursement policy. 

Experience:  

• Typically requires 2 years of related experience in a medical and/or cGMP regulated environment. 

• Experience with plasma or whole blood collections is preferred.   

• Experience working with adult learners, within an adult education programs is preferred.                                                                                  

Equivalency:  

• Depending on the area if assignment, directly related experience or a combination of directly related education and experience and or competencies may be considered in place of the stated requirements. 

Occupational Demands Form # 6: Work is performed in an office and/or a laboratory/manufacturing environment. Exposure to biological fluids with potential exposure to infectious organisms. Exposure to electrical office equipment. Exposure to miscellaneous production chemicals, moving machinery and production equipment. Exposure to high levels of noise on production floor.  Personal protective equipment required such as protective eyewear, garments and gloves.  Frequently sits for 2-4 hours per day. Repetitive hand movement of both hands with the ability to make fast, simple, repeated movements of the fingers, hands, and wrists.   Occasionally walks. Occasionally bends and twists neck. Light to moderate lifting and carrying objects with a maximum lift of 35lbs. Occasional travel within the United States. Able to communicate complex information and ideas so others will understand; with the ability to listen to and understand information and ideas presented through spoken words and sentences. 

Works independently with little guidance or reliance on oral or written instructions and plans work schedules to meet goals. 

Frequently interacts with others, relates sensitive information to diverse groups. Must work with diverse groups to obtain consensus on issues. Ability to apply abstract principles to solve complex conceptual issues.     

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