Provide proficient Quality Systems to increase company's growth by factoring compliance and production efficiency to deliver measurable results.
· Ensure center compliance with quality standards and regulations.
· Collaborate with Center Managers to ensure product quality, donor suitability and donor safety.
· Direct and monitor processes and ensure center compliance with all applicable state, federal, and company-designated regulations. Ensure that Standard Operating Procedures (SOPs) are properly interpreted, implemented in a timely fashion, and that the staff performs according to all SOPs.
· Ensure compliance with state and federal regulations, U.S. Food and Drug Administration (FDA)-approved Standard Operating Procedures, Occupational Safety and Health Administration (OSHA), Clinical Laboratory Improvement Amendments (CLIA), and Current Good Manufacturing Practice (cGMP).
· Maintain the highest production standards in accordance with state and federal regulations, U.S. Food and Drug Administration (FDA)-approved Standard Operating Procedures, Occupational Safety and Health Administration (OSHA), Clinical Laboratory Improvement Amendments (CLIA), and Current Good Manufacturing Practice (cGMP).
· Oversight of all aspects of internal and external audits including execution (if applicable). This includes documentation, review of and preparation of the response. 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; including direction, assignment of work, hiring, development and training, disciplinary actions, termination, maintenance of all personnel records, management of work schedule and delegation/follow-up of tasks.
· Work in collaboration with the Center Manager to develop the staff's knowledge.Document, investigate, and perform root cause analysis for deviations and customer complaints, specifically in how they relate to the safety of the donor and the quality of the products
l Responsible for all aspects of the donor center when the Center Manager is not present.
l Works with the Center Manager to develop action plans to maximize center efficiency and supervises the implementation of improvements. Collaborates with Training and Quality staff to ensure that training and quality goals are met.
l Responsible for all hiring, payroll, assignment and direction of work, development and training, disciplinary actions and termination and the maintenance of all personnel records.
l Directs and supervise employees. Review and approve employee schedules of 40 employees to accommodate donor cycles.
l Partners with the center manager in budget preparation and oversees facility to achieve production targets and quality goals at the agreed-upon cost structure.
l Determine the adequacy and adjust inventory levels of all goods and supplies necessary of the operation of the donor center. Compile and submit orders to vendors to meet determined inventory levels.
l Responsible for freezer management, including overseeing plasma shipments and equipment failures.
l Develop and implement advertising campaigns to improve production levels.
Builds rapport with donors to ensure overall customer satisfaction with the center to support long-term donation. Control center donor funds and ensure that all financial records are accurate and in order. Construct and submit timely and accurate reports on a daily/weekly/monthly or as required basis
· Assisted a center placed on a Quality Development Plan (QDP) - an evaluation plan to manage centers with potential quality and regulatory compliance risks.
· Responsibilities involved setting forth systems for improvement by considering the following factors: declining Key Point Indicators (KPIs) scores, increasing error rate and deviations, similar/repeat audit observations, and reduction of trends.
· Collaborated with Center Manager the center was re-evaluated over the course of 8 months and found significant and positive resulting in removal of center from a QDP in 2016.
· Reported to Head of Quality, Regional Quality Manager, General Manager, and Regional Operations Manager monthly.
· Over the course of 8 months the center' KPI scores improved, critical errors were eliminated, production improved through improved staff morale.
· Work with Area Leads to identify minor/major errors for improvement.
· Collaborate with Training Coordinator to increase SOP knowledge of all staff members. Root Cause Analysis and development of effective Corrective And Preventative Action (CAPA) for deviations identified utilizing a Deviation Reporting (Trackwise) that was evaluated by Regional Quality Manager (RQM)
· Ensure high product quality by following Good Manufacturing Practices (cGMP), Standard Operating Procedures (SOPs), and Food and Drug Administration (FDA) regulations.
· Ensure proper donor suitability, collection, processing, and shipment of product is according to standards and regulations.Verification of equipment policies, calibrations, and validation reports. Maintain data integrity by strict documentation of Key Performance Indicators (KPIs), annual improvement reports, and detailed incident reports
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