Quality Manager

Quality Manager

Location : FL-Kissimmee, US

Contract Type : Regular Full-Time

Area : GENERAL MANAGEMENT

Req Id : 537545

Would you like to join an international team working to improve the future of healthcare? Do you want to enhance the lives of millions of people? Grifols is a global healthcare company that since 1909 has been working to improve the health and well-being of people around the world. We are leaders in plasma-derived medicines and transfusion medicine and develop, produce and market innovative medicines, solutions and services in more than 110 countries and regions.

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.

Job Requirments : 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.

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.