Quality Assurance and Training Coordinator

Would you like to join an international team working to improve the future of healthcare? Do you want to enhance the lives of millions of people? Grifols is a global healthcare company that since 1909 has been working to improve the health and well-being of people around the world. We are leaders in plasma-derived medicines and transfusion medicine and develop, produce and market innovative medicines, solutions and services in more than 110 countries and regions.

About the role

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 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.

Responsibilities

• 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 to ensure center compliance with all applicable state, federal, and company-designated regulations, ensuring SOPs are properly interpreted, implemented, and followed.
• Interprets and implements processes, regulations, and SOPs for quality control and regulatory compliance, making independent decisions and modifications as required.
• Provides oversight of all aspects of internal and external audits, including execution (if applicable), documentation, review, preparation of responses, and implementation of corrective and preventive actions.
• Continuously assesses, promotes, and improves the effectiveness of quality systems through trend recognition, investigation of procedural failures, direct employee observation, and document review.
• Oversees product and biohazard waste shipments, ensuring compliance with regulatory specifications, product release requirements, accurate labeling, and documentation.
• Performs reviews of all test results and verifies proper documentation of unsuitable donors.
• Collaborates with the Center Manager to develop staff knowledge of job functions and their impact on the end product and patient.
• Documents, investigates, and performs root cause analysis for deviations and customer complaints, focusing on donor safety and product quality.
• Documents and tracks center quality incidents, follows up on incidents/errors, and reports critical incidents and trends to the Center Manager.
• Reports compliance status to necessary parties.
• Reviews SOPs with trainees and assesses job skills during training.
• Ensures accuracy of donor files and quality of supplies and materials, initiating investigations for non-conformance.
• Directs maintenance, calibration of equipment, and documentation of procedures.
• Monitors training documents for compliance with policies and procedures, ensuring job and cGMP training is completed, documented, and filed.
• Tracks and trends corrective and preventive actions, system implementations, and process improvements to measure effectiveness.
• Ensures quality control checks are performed and test reagents are within acceptable ranges.
• Directs routine verification of SOPs and forms to ensure 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.
• Prepares quality analysis reports to track issues and set goals, conducting in-depth research to resolve systemic compliance issues.
• Builds rapport with donors to ensure customer satisfaction and support long-term donation.
• Reviews and approves deferred donor reinstatement activities.
• Performs reviews of lookback information and medical incident reports with related documentation.

Requirements

• 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 under Grifols Tuition Reimbursement policy.
• 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 adult education programs is preferred.
• Directly related experience or a combination of education and experience may be considered in place of stated requirements, depending on the area of assignment.

Skills

• Strong interpersonal communication, organizational, and problem-solving abilities.
• Ability to understand and assess FDA regulations.
• Strong integrity and commitment to quality and compliance.
• Proficiency in mathematics and legible handwriting.
• High level of proficiency with computers.
• Proficient in root cause analysis and corrective/preventive actions.
• Ability to balance multiple competing priorities and manage time effectively.
• Proven ability to maintain high quality and compliance standards and integrate into the center leadership team.
• Ability to work with minimal supervision.
• Ability to travel when needed for meetings, events, and occasional support of other centers.
• Able to communicate complex information clearly and listen to and understand information presented through spoken words.
• Works independently with minimal guidance, planning work schedules to meet goals.
• Frequently interacts with others, relating sensitive information to diverse groups and working with them to obtain consensus on issues.
• Ability to apply abstract principles to solve complex conceptual issues.

Occupational Demands

• Work is performed in an office and/or laboratory/manufacturing environment.
• Exposure to biological fluids with potential exposure to infectious organisms.
• Exposure to electrical office equipment, miscellaneous production chemicals, moving machinery, and production equipment.
• Exposure to high levels of noise on the 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.
• Occasional walking, bending, and twisting of the neck.
• Light to moderate lifting and carrying objects with a maximum lift of 35 lbs.
• Occasional travel within the United States.