Quality Manager - Statesboro

GRIFOLS, S.A.•Statesboro, GA

About The Position

The Center Quality Manager provides independent quality inspection and control to ensure the donor center complies with quality standards, regulations, and company requirements. The role collaborates with the Center Manager on product quality, donor suitability, and donor safety, and interprets and implements applicable processes, regulations, and SOPs. The manager makes independent decisions and modifications as needed to maintain regulatory compliance and effective quality systems. The position oversees audits, corrective and preventive actions, investigations, quality documentation, staff training, equipment maintenance and calibration, and product and biohazard waste shipments. It also reviews unsuitable test results and donor files, monitors quality control checks and training records, analyzes quality trends, prepares reports, and works to resolve systemic compliance issues. The manager supervises Quality Associates and builds rapport with donors to support customer satisfaction and long-term donation.

Requirements

Bachelor of Science degree or equivalent.
Certified and proficient in quality and compliance.
Certification as a Designated Trainer for the quality area is required.

Nice To Haves

Works toward American Society for Quality certification as a Certified Quality Auditor.

Responsibilities

Ensure center compliance with quality standards and regulations through independent quality inspection and control.
Collaborate with Center Managers to ensure product quality, donor suitability, and donor safety.
Direct and monitor processes to ensure compliance with applicable state, federal, and company-designated regulations.
Ensure SOPs are interpreted and implemented promptly and that staff follow them.
Interpret and implement quality-control and regulatory-compliance processes, regulations, and SOPs; make independent decisions and modifications as required.
Oversee internal and external audits, including execution when applicable, documentation, review and preparation of responses, corrective and preventive actions, assessment, and follow-up.
Continuously assess and improve donor-center quality systems by identifying trends, investigating procedural failures, observing employees, and reviewing center documents.
Direct, assign, and oversee the work of Quality Associates, including hiring, development, training, discipline, and termination.
Oversee product and biohazard waste shipments; ensure regulatory and product-release requirements, accurate labeling and documentation, and authorize final shipment.
Review documentation of unsuitable test results and disposition of associated results.
Document, investigate, and perform root-cause analysis for deviations and customer complaints related to donor safety and product quality.
Document and track quality incidents, identify trends, follow up on incidents and errors, and report critical incidents and problematic trends to the Center Manager.
Report compliance status to necessary parties and ensure donor-file accuracy.
Direct equipment maintenance and calibration and ensure procedures are documented.
Ensure CLIA proficiency test surveys, complaint investigations, and training are properly documented.
Monitor training documents and ensure job and cGMP training is completed, documented, and on file.
Ensure required QC checks are performed and test-reagent results are within acceptable ranges.
Direct routine verification of SOPs and forms to ensure the Donor Center manual is current.
Partner with the Center Manager on donor suitability activities and manage donor deferrals as appropriate.
Prepare quality analysis reports, track issues, set goals, and conduct in-depth research and analysis to resolve systemic compliance issues.
Build rapport with donors to support center customer satisfaction and long-term donation.