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Thorough Quality Assosicate with five years experience in the plasma industry. Excellent resource management and allocation skills. Outstanding communication, organizational and time management talents. I am a very determined Quality Associate with dedication to quality and accuracy. Familiar with handling multiple projects in highly competitive environments. Solid interpersonal and collaboration skills.
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- Completed deviation forms and recorded findings of inspection process, collaborating with quality team members and department managers to implement procedural remedies.
- Provided regular updates to team leadership on quality metrics, communicating consistency problems or production deficiencies with quality and production leadership.
- Developed monthly, end-of-quarter and other statistical reports like KPI'S, including analysis for leadership team and for quality improvement program outcomes studies.
- Provided analytical, planning and coordination support on projects as assigned, reviewing, interpreting, analyzing and illustrating data to stimulate and support enlightened decision making.
- Educated employees on specific QA standards and confirmed maintenance of standards.
- Routinely tested products to align temperature regulations and specifications with quality standards.
- Monitor product standards and quality-control programs.
- Kept inspection journals and daily summary logs as required.
- Collaborated with management to provide training on improved processes and assist with creation and maintenance of quality training.
- Fix technical issues effectively to increase productivity and boost workflows.
- 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 and performs product and biohazard waste shipments: 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.
- Work with organization members to audit, identify quality problems, and improve operational processes.
- Write, maintain, and disseminate quality manuals and other documentation.
- Investigate and diagnose quality complaints, track down components, and recommend corrective actions.Write deviation records and set CAPAs in place for employees
- Verify logs, databases, and other data to track and flag quality concerns and improvements.
- Assist with audits such as internal compliance, FDA and EMA.
- Monitored product standards and quality-control programs.
- Do routine observations on employees to ensure SOP's and compliance regulations are being followed
Subject matter area expert in the center
ensures donor and production flow in the center
problem solving in all areas of the center
Assist in determining the suitability of donors to undergo plasmapheresis prior to venipuncture. establish rapport with donors to ensure overall customer happiness with the center to support long-term donation, all while ensuring donor confidentiality. Respond to and assist with handling donor reactions in accordance with guidelines.Monitors donor and equipment to ensure health of donors and quality of product. Sets up, disconnects, and operates the automated plasmapheresis machines including response and evaluation of all autopheresis troubleshooting displays, documentation of exceptions, etc. Ensures the proper calibration and maintenance of autopheresis machines and associated equipment.Disconnects and disposing of all contaminated disposable equipment. Ensures proper cleaning of equipment and work area between donors. Maintains accurate and thorough documentation of production records.Learns and maintains thorough familiarity and compliance with all state and federal regulations, FDA-approved Standard Operating Procedure Manual, Occupational Safety and Health Administration (OSHA), Clinical Laboratory Improvement Amendments (CLIA), Current Good Manufacturing Practice (cGMP) and internal company procedures. Organized daily work based on collection priority. Lead all Phlebotomist on donor floor. Strategically move employees around to best suit the donor floor. Ability to trouble shot effectively. Ability to assist other with hard sticks and procedures.
Southern New Hampshire University - Hooksett, NH
Lake Central High School - Saint John, IN
I received a scholarship for the College of America for Logistics Management in 2020.
I assisted the Regional Quality Manager in a DCA audit.
I became a designated trainer for Quality
I received a Promotion to Quality Associated II
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School Attended
- Southern New Hampshire University
- Lake Central High School
Job Titles Held:
- Quality Associate II
- Quality Associate I
- Donor Center Specialist
- Lead Phlebotomist
Degrees
- No Degree
- High School Diploma
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