Quality Manager

Center Quality Manager Responsibilities Independent level of quality inspection and control—ensures center compliance with quality standards and regulations. Collaborates with Center Managers to ensure product quality, donor suitability, and donor safety. Directs and monitors processes and ensures center compliance with all applicable state, federal, and company‑designated regulations. Ensures that SOPs are properly interpreted, implemented in a timely fashion, and that staff performs according to all SOPs. Interprets and implements processes, regulations, and SOPs for quality control and overall regulatory compliance, making independent decisions and modifications as required. Oversight of all aspects of internal and external audits—including execution (if applicable); documentation, review, and preparation of the response. Implements corrective and preventive action, assesses corrective and preventive actions, and follows up as required. Continuously assesses, promotes, and improves the effectiveness of the quality systems in the donor center through recognition of trends, investigation of failures in the execution of procedures, direct employee observation, and review of center documents. Responsible for the personnel functions of the Quality Associates; direction, assignment of work, hiring, development and training, disciplinary actions, termination, and maintenance of all related personnel records. Oversees product and biohazard waste shipments: ensures shipments meet regulatory specifications and product release requirements, accurate labeling and documentation, and authorizes final shipment. Reviews documentation of unsuitable test results and the disposition of the associated results. Documents, investigates, and performs root cause analysis for deviations and customer complaints, specifically in how they relate to the safety of the donor and the quality of the product. Documents and tracks/trends center quality incidents and follows up on incidents/errors as required; reports critical incidents and problematic trends to the Center Manager. Reports compliance status to necessary parties. Ensures accuracy of donor files. Directs the maintenance and calibration of equipment and documentation of procedures. Ensures that CLIA proficiency test surveys, complaint investigations, and training have been properly documented. Monitors training documents to ensure compliance with all applicable policies and procedures. Ensures that job and cGMP training is completed, documented, and on file. Ensures that quality control (QC) checks are performed as required and are within acceptable ranges for test reagents. QM directs routine verification of the SOPs and forms to ensure they are up to date in the Donor Center’s manual. Partners with the Center Manager to determine donor suitability activities and manages donor deferrals as appropriate. Prepares quality analysis reports to track issues and set goals; conducts in‑depth research and analysis to resolve systemic compliance issues. Builds rapport with donors to ensure overall customer satisfaction with the Center and support long‑term donation. Qualifications Bachelor of Science degree or equivalent. Certified and proficient in quality and compliance. Works toward certification from the American Society for Quality to be a Certified Quality Auditor. Certification as a Designated Trainer for quality area is required. Location NORTH AMERICA : USA : FL‑St. Petersburg:USSTP - St Petersburg FL-38th Ave Equal Employment Opportunity Grifols provides equal employment opportunities to applicants and employees without regard to race; color; sex; gender identity; sexual orientation; religious practices and observances; national origin; pregnancy, childbirth, or related medical conditions; status as a protected veteran or spouse/family member of a protected veteran; or disability. We will consider for employment all qualified applicants in a manner consistent with the requirements of all applicable laws. #J-18808-Ljbffr