Quality Systems & Training Leader (Donor Center)

Grifols; Tennessee; On-site; USD 110,000 - 140,000; Full time

Job summary

Grifols in Chattanooga, TN is seeking a Quality Systems & Training Manager to evaluate processes, develop action plans, and coordinate the strategic implementation of quality system processes and corrective actions at the plasma donor center. This role ensures product quality and donor safety through SOPs, audits, and CAPA programs.

The position reports to the Center Manager and emphasizes staff competency, training records, and continuous improvement in a regulated environment.

Qualifications

• Bachelor of Science degree or equivalent.

Responsibilities

• Maintains oversight of the center’s quality management system and ensures continuous quality improvement, by addressing deficiencies in a timely manner and communicating concerns to the appropriate parties.
• Directs and monitors processes and ensures center compliance with all applicable state, federal, and company-designated regulations. Implements SOPs for quality control and compliance.
• Maintains oversight of center training program by ensuring compliance to program requirements and promoting staff competency.
• Collaborates with Center Manager to ensure donor center operates with product quality, donor suitability and safety maintained.
• Oversees personnel functions of the Quality Associate, including hiring, development, training, and performance management.
• Oversees all aspects of internal and external audits including audit preparation, execution, corrective actions, and follow-up.
• Promotes effectiveness of quality and training systems through trend recognition and investigation of failures.
• Documents, investigates, and performs root-cause analysis for deviations and customer complaints related to safety and quality.
• Investigates trends and follows up on corrective actions, system implementations, and process improvements.
• Oversees product and biohazard waste shipments, labeling, documentation, and final shipment authorization.
• Reviews documentation of unsuitable test results and donor adverse event reports as applicable.
• Ensures annual training is completed and documented; conducts training observations for competency.
• Ensures supplies meet quality requirements and are stored properly; initiates investigations for non-conformance.
• Determines donor suitability activities and manages donor deferrals as appropriate.
• Prepares quality analysis reports to track issues and goals; conducts in-depth research to resolve systemic issues.
• Ensures CLIA proficiency test surveys and related documentation are properly recorded.
• Holds monthly Quality Meeting to communicate status updates and manage actions.

Skills

Quality management

Training programs

Regulatory compliance

Process improvement

Education

Bachelor of Science degree or equivalent

Job description

Grifols in Chattanooga, TN is seeking a Quality Systems & Training Manager to evaluate processes, develop action plans, and coordinate the strategic implementation of quality system processes and corrective actions at the plasma donor center. This role ensures product quality and donor safety through SOPs, audits, and CAPA programs.

The position reports to the Center Manager and emphasizes staff competency, training records, and continuous improvement in a regulated environment.