Plasma Center Quality Manager

Grifols•San Antonio, TX

1d•Onsite

About The Position

The Plasma Center Quality Manager, referred to in the posting as the Quality Systems Manager (QSM), oversees the plasma donor center’s quality management and training systems. The role evaluates processes, develops action plans, coordinates quality-system improvements and corrective actions, and ensures compliance with applicable regulations and company requirements. It supports product quality, donor suitability, and donor safety in collaboration with the Center Manager. The position oversees audits, investigations, corrective and preventive actions, training records, supply quality, donor suitability and deferrals, and the review and authorization of product and biohazard waste shipments. It also prepares quality analysis reports, investigates systemic compliance issues, maintains relevant testing and complaint documentation, and leads monthly quality meetings. The role supervises the Quality Systems Associate and may travel to meetings, events, and other centers as needed. Work is performed in an office and/or laboratory/manufacturing environment, with potential exposure to biological fluids, infectious organisms, cold temperatures, chemicals, machinery, and production-floor noise. Required personal protective equipment includes protective eyewear, garments, and gloves. The position frequently involves sitting, repetitive hand movements, driving to site locations, and interacting with diverse groups; it also involves occasional walking, bending, twisting, and lifting or carrying up to 35 pounds.

Requirements

Bachelor of Science degree or equivalent; directly related experience, education, and/or competencies may be considered in place of stated requirements depending on the assignment.
Typically requires 2 years of related experience in a medical and/or cGMP-regulated environment.
Strong 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 and legible handwriting.
High proficiency with computers.
Proficiency in root-cause analysis and corrective and preventive actions.
Ability to balance competing priorities and manage time effectively.
Ability to maintain high quality and compliance standards and contribute to the center leadership team.
Ability to work with minimal supervision.
Ability to travel when needed for meetings, events, and occasional support of other centers.
Ability to communicate complex information clearly, listen and understand spoken information, work independently, plan schedules to meet goals, interact with diverse groups, handle sensitive information, build consensus, and apply abstract principles to complex conceptual issues.
Ability to meet the occupational demands described, including frequent sitting and repetitive hand movements; occasional walking, bending, and twisting; and light to moderate lifting and carrying up to 35 pounds.
Ability to use required personal protective equipment, including protective eyewear, garments, and gloves.

Nice To Haves

Experience with plasma or whole blood.

Responsibilities

Evaluate processes, develop action plans, and coordinate implementation of quality-system processes and corrective actions at the plasma donor center.
Maintain oversight of the center’s quality management system and address deficiencies in a timely manner, communicating concerns to appropriate parties.
Direct and monitor processes to ensure compliance with applicable state, federal, and company-designated regulations.
Implement Standard Operating Procedures for quality control and regulatory compliance.
Oversee the center training program, maintain and audit training records, and promote staff competency.
Collaborate with the Center Manager to help ensure product quality, donor suitability, and donor safety.
Direct the Quality Systems Associate, including assigning and following up on work, hiring, training and development, scheduling, personnel records, discipline, and termination.
Oversee internal and external audits, including preparation, execution, responses, corrective and preventive actions, assessment, and follow-up.
Assess and improve quality and training systems by recognizing trends, investigating procedural failures, and conducting direct observations.
Document and investigate deviations and customer complaints, perform root-cause analysis, and follow up on trends and corrective and preventive actions to assess effectiveness.
Oversee product and biohazard waste shipments, verify regulatory and product-release requirements and accurate documentation, and authorize final shipment.
Review documentation of unsuitable test results, unit lookback information, donor adverse-event reports, and related records.
Ensure required annual job and center training is completed, documented, and filed; observe employee training to verify competency before independent work.
Verify supplies and materials meet quality requirements and are stored appropriately; initiate investigations or reject nonconforming supplies when needed.
Determine donor suitability activities, manage donor deferrals, and review and approve deferred donor reinstatements.
Prepare quality analysis reports, conduct research and analysis to resolve systemic compliance issues, and ensure documentation of CLIA proficiency test surveys, complaint investigations, and training.
Hold monthly Quality Meetings to communicate status updates and manage action outcomes.
Travel as needed for meetings, events, and occasional support of other centers.