Plasma Center Quality Manager

GRIFOLS, S.A.•San Antonio, TX

3d•Onsite

About The Position

The Plasma Center Quality Manager (identified in the description as Quality Systems Manager) oversees the plasma donor center’s quality management and training systems. The role supports regulatory compliance, product quality, donor suitability and safety, and continuous improvement. It also supervises the Quality Systems Associate and works with the Center Manager to ensure effective center operations. The manager coordinates quality-system processes and corrective actions, monitors compliance with applicable regulations and company procedures, oversees audits and investigations, and evaluates the effectiveness of corrective and preventive actions. The role reviews donor-related documentation, oversees regulated product and biohazard waste shipments, manages training and competency records, and prepares quality analyses and reports. Work is performed in an office and/or laboratory/manufacturing environment, with exposure to biological fluids, production equipment, chemicals, cold temperatures, and noise. The position may require travel to meetings, events, and other centers.

Requirements

Bachelor of Science degree or equivalent; directly related experience, education, and/or competencies may be considered as an equivalency depending on the assignment.
Typically, 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 strong time-management abilities.
Demonstrated ability to maintain a high level of quality and compliance and contribute to the center leadership team.
Ability to work with minimal supervision.
Ability to travel as needed for meetings, events, and occasional support of other centers.
Ability to communicate complex information clearly and understand spoken information.
Ability to work independently, plan schedules to meet goals, interact with others, handle sensitive information, and work with diverse groups to reach consensus.
Ability to apply abstract principles to solve complex conceptual issues.
Able to meet the stated occupational demands, including frequent sitting and driving, repetitive hand movements, occasional walking and bending or twisting the neck, and lifting or carrying up to 35 pounds.
Able 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 strategic 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 promptly, 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 ensure staff competency in assigned duties.
Collaborate with the Center Manager to maintain product quality, donor suitability, and donor safety.
Manage personnel functions for the Quality Systems Associate, including direction, work assignment, hiring, development, training, discipline, termination, personnel records, scheduling, and task follow-up.
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 identifying trends, investigating procedural failures, and conducting direct observations.
Document and investigate deviations and customer complaints, and conduct root-cause analysis related to donor safety and product quality.
Investigate trends and follow up on corrective and preventive actions, system implementations, and process-improvement plans to evaluate their effectiveness.
Oversee product and biohazard waste shipments, ensuring regulatory specifications, product-release requirements, accurate labeling and documentation, and authorization of final shipment.
Review documentation of unsuitable test results and unit-lookback information.
Review donor adverse-event reports and related documentation.
Ensure required annual job and center training is completed, documented, and retained.
Observe employee training to verify staff competency before releasing employees to work independently.
Ensure supplies and materials meet quality requirements and are stored under appropriate temperature and facility conditions; initiate investigations or reject nonconforming supplies as appropriate.
Determine donor-suitability activities, manage donor deferrals, and review and approve deferred-donor reinstatements.
Prepare quality-analysis reports to track issues and set goals, and conduct in-depth research and analysis to resolve systemic compliance issues.
Ensure CLIA proficiency-test surveys, complaint investigations, and training are properly documented.
Conduct monthly Quality Meetings to communicate status updates and manage action outcomes.