Quality Manager

Grifols•Stonecrest, GA

13d

About The Position

The Quality Manager provides independent quality inspection and control for a donor center, ensuring compliance with quality standards and applicable regulations. The role collaborates with Center Managers on product quality, donor suitability, and donor safety, and interprets and implements quality-control processes, regulations, and SOPs, making independent decisions and modifications as needed. The Quality Manager oversees internal and external audits, including documentation, responses, corrective and preventive actions, assessment, and follow-up. The role continuously evaluates and improves the effectiveness of center quality systems through trend recognition, procedure-failure investigations, employee observation, and document review. It also manages Quality Associate personnel functions and oversees product and biohazard waste shipments, ensuring regulatory compliance, accurate labeling and documentation, and authorization of final shipment. Additional responsibilities include reviewing unsuitable test results and related dispositions; investigating deviations and customer complaints; tracking and reporting quality incidents and trends; ensuring donor-file accuracy; overseeing equipment maintenance and calibration; monitoring training and quality-control documentation; maintaining current SOPs and forms; managing donor deferrals in partnership with the Center Manager; preparing quality analysis reports and investigating systemic compliance issues; and building donor rapport 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 certification from the American Society for Quality 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.
Interpret and implement SOPs in a timely manner and ensure staff perform according to them.
Interpret and implement quality-control and regulatory-compliance processes, making independent decisions and modifications as required.
Oversee internal and external audits, including execution when applicable, documentation, response preparation and review, and corrective and preventive action implementation, assessment, and follow-up.
Assess and improve donor-center quality systems by identifying trends, investigating procedure failures, observing employees, and reviewing center documents.
Direct Quality Associate personnel functions, including work assignment, hiring, development, training, discipline, and termination.
Oversee product and biohazard waste shipments, ensuring regulatory specifications, product-release requirements, accurate labeling and documentation, and final-shipment authorization.
Review documentation of unsuitable test results and disposition of associated results.
Document and investigate deviations and customer complaints, perform root-cause analysis, and address issues relating to donor safety and product quality.
Document, track, and trend center quality incidents; follow up on incidents and errors; and report critical incidents and problematic trends to the Center Manager.
Report compliance status to necessary parties.
Ensure donor files are accurate.
Direct equipment maintenance and calibration and documentation of procedures.
Ensure CLIA proficiency test surveys, complaint investigations, and training are properly documented.
Monitor training documents for compliance with applicable policies and procedures.
Ensure job and cGMP training is completed, documented, and on file.
Ensure required QC checks are performed and test reagents are within acceptable ranges.
Direct routine verification that SOPs and forms in the Donor Center manual are up to date.
Partner with the Center Manager to determine donor-suitability activities and manage donor deferrals as appropriate.
Prepare quality analysis reports to track issues and set goals; research and analyze systemic compliance issues in depth.
Build rapport with donors to support center customer satisfaction and long-term donation.