Quality Systems Manager for Plasma Center

Summary

Evaluates processes, develops action plans, and coordinates the strategic implementation of system processes and corrective actions at the plasma donor center. Reports to the Regional Quality Manager.

Primary Responsibilities

• Maintains oversight of the center's quality management system and ensures continuous quality improvement, addressing deficiencies in a timely manner and communicating concerns to appropriate parties.
• Directs and monitors processes and ensures center compliance with all applicable state, federal, and company-designated regulations.
• Implements Standard Operating Procedures (SOPs) for quality control and overall regulatory compliance.
• Collaborates with Center Manager to ensure the donor center operates in a manner that assures product quality, donor suitability and donor safety.
• Responsible for personnel functions of the Quality Systems Associate, including direction, assignment of work, hiring, development and training, disciplinary actions, termination, personnel records, work schedule and delegation/follow-up of tasks.
• Responsible for oversight of all aspects of internal and external audits including audit preparation, execution, response, implementation of corrective/preventative actions, assessment of corrective actions, and follow-up.
• Continuously assesses, promotes, and improves the effectiveness of the quality and training systems through recognition of trends, investigation of failures in the execution of procedures, and direct observations.
• Documents, investigates, and performs root-cause analysis for deviations and customer complaints related to donor safety and product quality.
• Investigates identified trends and performs follow-up on corrective and preventive actions, system implementations, and process improvement plans to measure effectiveness.
• Oversees product and biohazard waste shipments: ensures shipments meet regulatory specifications and product release requirements; ensures accurate labeling and documentation; authorizes final shipment.
• Performs a review of the documentation of unsuitable test results and unit lookback information.
• Performs a review of donor adverse event reports and applicable related documents.
• Ensures job and center annual training (e.g., Advanced cGMP, Blood Borne Pathogen) is completed, documented, and on file.
• Performs employee training observations to ensure staff competency prior to releasing employees to work independently.
• Ensures all supplies and materials ordered meet quality requirements prior to use and are stored in appropriate temperature/facility conditions; initiates investigations and rejection of supplies for non-compliance.
• Determines donor suitability activities and manages donor deferrals as appropriate.
• Reviews and approves deferred donor reinstatement activities.
• Prepares quality analysis reports to track issues and set goals.
• Does in-depth research and analysis to resolve systemic compliance issues.
• Ensures CLIA proficiency test surveys, complaint investigations, and training have been properly documented.
• Holds monthly Quality Meeting to communicate status updates and manage action outcomes.

Other Responsibilities

Leads projects and initiatives as requested. Managers and supervisors may assign other duties as needed.

Job Requirements

EDUCATION: Bachelor of Science degree or equivalent. Certified and proficient in quality and compliance.

EXPERIENCE: Typically requires 2-5 years of related experience in a medical and/or cGMP regulated environment. Experience with plasma or whole blood.

EQUIVALENCY: Depending on the area of 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.

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.