Quality Assurance Control
Resume:
TAYLOR KAETER
SUMMARY
Detail-oriented professional committed to improving organizational outcomes by monitoring performance initiatives. Focused on planning, implementing, and optimizing procedures. Specializing in operations and dedicated to maximizing quality. Efficient Quality Coordinator known for high productivity and ability to complete tasks swiftly and accurately. Specialize in process improvement, regulatory compliance, and quality control management. Excel in problem-solving, teamwork, and communication, ensuring seamless operations and consistent product quality. EXPERIENCE
Quality Coordinator
Takeda BioLife Plasma Services Bannockburn, IL August 2022 - July 2024
• Coordinated with external agencies such as FDA inspectors during routine visits or special investigations.
• Ensured all necessary documentation is completed accurately according to company policies and procedures.
• Participated in regular meetings with management staff members providing updates on current projects, trends in the industry.
• Created reports summarizing key findings from inspections, investigations, audits and other activities related to quality control.
• Analyzed data collected from testing laboratories for accuracy and completeness of results prior to release of products into the market place.
• Maintained records including documentation of test results, Quality Assurance and Control activities and other pertinent information related to product quality control. Senior Quality Assurance Specialist
Takeda BioLife Plasma Services Bannockburn, IL November 2016 - August 2022
• Developed and implemented quality assurance standards to ensure the highest level of product safety and reliability.
• Conducted audits to ensure adherence to established policies, procedures, and regulations.
• Collaborated with cross-functional teams to troubleshoot issues and recommend corrective actions.
• Determined training needs of staff and organized training interventions to achieve quality standards.
• Coordinated user acceptance testing activities with stakeholders such as business analysts and developers.
• Prepared detailed reports summarizing QA results including recommendations for corrective action when necessary.
• Produced test scripts for new automated software testing rounds.
• Established metrics and performance indicators for measuring the effectiveness of quality assurance processes.
CONTACT
************@*****.***
Elk Grove Village, IL 60007
Bold Profile
SKILLS
• Customer Satisfaction
• Material Specifications
• Visual inspections
• Critical Thinking Skills
• Operational Excellence
• Quality Management Systems
• Customer Service
• Document Control
• Audit Compliance
• Corrective Actions
• Relationship Building
• Internal Auditing
• Training and Development
EDUCATION
Bachelor of Science
St. Cloud State University, St. Cloud, MN
ACCOMPLISHMENTS:
• Nearly 18 years of BioLife / Takeda
company experience
• Reported Viral Marker Data monthly
to PPTA per Regulations
• Responsible for multiple SharePoint
sites
Quality Management Representative
BioLife Plasma Services Maple Grove, MN July 2015 - November 2016
• Opened a new plasma donation center with consecutive successful audits and inspections (PPTA, CLIA, PQAG (internal Plasma Quality Audit Group), FDA, and EMA).
• Ensured center compliance with all federal, state, local, and company-specific regulations related to the quality of the product, employee, and donor safety.
• Assisted in the development and implementation of quality management systems.
• Reviewed customer requirements to ensure compliance with applicable regulations.
• Evaluated nonconforming products and services to determine the root causes of defects.
• Developed corrective action plans for identified issues and monitored the effectiveness of resolutions.
Master Plasma Center Technician
BioLife Plasma Services St. Cloud, MN May 2009 - October 2016
• Performed daily maintenance on centrifuge and other laboratory equipment.
• Assisted in the collection of plasma donations from donors.
• Maintained accurate records of donor collections, including volume and type of donation.
• Provided basic medical care to donors during their donation process as needed.
• Educated donors about the importance of donating plasma safely and responsibly. Training Supervisor
BioLife Plasma Services Waite Park, MN June 2013 - July 2015
• Conducted regular assessments of employee performance to identify areas needing improvement.
• Instructed trainees on proper use of office equipment and software applications.
• Assisted with onboarding process by providing orientation materials to new hires.
• Developed and implemented training programs for new employees.
• Transitioned Learning Management Systems
Center Supervisor
BioLife Plasma Services St. Cloud, MN September 2011 - June 2013
• Responsible for all job duties associated with the screening, processing, and sample collection for new and repeat donors, as well as center leadership and training Center Line Staff
BioLife Plasma Services St. Cloud, MN July 2006 - May 2009
• Assisted with the development and implementation of staff policies and procedures.
• Provided support to management in areas such as recruitment, training, performance reviews, and disciplinary actions.
• Developed strategies for improving customer service standards and increasing customer satisfaction levels.
• Participated in the planning of special events and promotions for the organization. PROJECTS
Internal Audit Team Member, Supplier Management Support for backlog, TrackWise SME for Deviation and CAPA, Lead initiative to transfer minor level errors from SharePoint to TrackWise, Well trained in TrackWise for Change Control and Supplier Management, Regulatory Affairs Support – BPDR, Lookback Support – PDIR (Post Donation Information Reporting)
REFERENCES
References available upon request.
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