Grifols Shared Services North America, Inc Quality Manager in Baton Rouge, Louisiana
Grifols is a global healthcare company whose mission is to improve the health and well-being of people. Our three divisions –Bioscience, Diagnostic and Hospital–develop, produce and market our innovative products and services to medical professionals in more than 100 countries.
We are committed to fostering an environment that creates continuous learning opportunities and encourages professional development and growth. As a company devoted to improving the health and well-being of people, we are looking for talented professionals worldwide. Make a difference and join us in this challenging and rewarding enterprise.
Center Quality Manager
Primary Responsibilities for role:
● 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 Standard Operating Procedures (SOPs) are properly interpreted, implemented in a timely fashion, and that the 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). This includes documentation, review of and preparation of the response.
Also including implementation of corrective and preventative action, assessment of corrective and preventative actions and follow-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 Assoc(s); including direction, assignment of work, hiring, development and training, disciplinary actions, termination, maintenance of all
● Oversees product and biohazard waste shipments: Ensures shipments meet regulatory specifications and product release requirements; ensures accurate labeling and documentation; and, authorizes final shipment.
● Performs a review of the 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 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 Clinical Lab Improvement Amendments (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 Current Good Manufacturing Practice (cGMP) training is completed, documented, and on file.
● Ensures that quality control (QC) checks are performed as required and are in acceptable ranges for test reagents.
● QM directs routine verification of the SOP and forms to ensure that 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. Does in depth research and analysis to resolve systemic compliance issues.
● Builds rapport with donors to ensure overall customer satisfaction with the Center to support long-term donation.
Bachelor of Science degree or equivalent. Certified and proficient in quality and compliance. Works toward certification from American Society for Quality to be a Certified Quality Auditor. Certification as a Designated Trainer for quality area is required.
Location: USA- North America
Biomat - 5906 Airline Hwy Ste 101 Baton Rouge, LA 70805
Learn more about Grifols at http://www.grifols.com/es/web/international/home