Over 5 years of leadership and quality management experience in a biomedical facility including; evaluating data in accordance with Standard Operating Procedure, training and providing feedback to staff persons in order to maintain compliance in a federally regulated environment. Offers strong problem solving, investigation of failure modes as well as implementation of Corrective and Preventive actions. Offers over 5 years of experience in managing regulated documents, over sight of staff persons operating in accordance with Standard Operating Procedure and oversight to ensure that Quality products are priority and commitment to quality performance. Seeking to obtain a Quality Assurance Management position where I can utilize my skills and experience to assist your team and company in achieving departmental goals.
❖ Emergency Medical Technician Certification (2013)
❖ Cardiopulmonary Resuscitation Certification (CPR) 2012
TECHNOLOGY SKILLS ❖ Proficient in Microsoft Office Suite (Word, Excel, Access, and Power Point) Proficient in Donor Management System (DMS), SMART CAPA, National Biomedical Computer System (NBCS), Foot Prints, Odyssey, Component Distribution Information System (CDIS), Donor Management Information System (DMIS),National Donor Deferral Registry (NDDR) ePROGESA,TrackWise, Compliance Wire
Independent level of quality inspection and control - Ensures center compliance with quality standards and regulations. Collaborates with Regional Quality 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. 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 Associate(s); 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. 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. Works in collaboration with the Center Manager to develop the staff's knowledge of their job function and how their performance relates to the end product and patient. 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.Lead investigations to determine root cause, corrective/preventive actions, and appropriate coordination/ leadership of process improvements. Lead and develop direct reports ensuring they are competently skilled to perform their QA roles. Conducts competency checks/observations of all staff.
* Acts as lead supervisorin ensuring the day-to-day activities of quality operations are compliant with Standard Operating Procedures and applicable federal and local regulations as well as HR polices. * Develops quality knowledge and assists with identifying problem areas and implement corrective action as needed. * Collects and analyze data to support continuous improvement resulting in improved customer service/donor service, product yields and financial results while maintaining compliance and quality. * Participates in review findings, deviation management and written responses to ensure a successful closure of audits.
- Providing customers with a quick and efficient check-out experience - Ensuring customers receive courteous service - Ensuring all company policies are followed with regard to payment options and current prices - Maintaining brand standards at the front end area and sales floor - Answering customer questions and restocking items efficiently and accurately
American Red Cross Smart CAPA(Corrective action/Preventive Action Certification,Emergency Medical Technician Certification,Cardiopulmonary Resuscitation(CPR) Certification
National Honor Society,
ASQ Global Leader in Quality
*6 years Management/leadership
*4 years Investigation/Decision Making/Problem Solving
*Strong organizational skills and attention to detail
*Understand Regulatory Standards/Root Cause Analysis/Audit Preparation
Resumes, and other information uploaded or provided by the user, are considered User Content governed by our Terms & Conditions. As such, it is not owned by us, and it is the user who retains ownership over such content.
Companies Worked For:
Job Titles Held: