Summary
Overview
Work History
Education
Skills
Timeline
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Nicole Butler

Lincoln,NE

Summary

Adaptable Quality Manager with a 3-year background in implementing and developing improvement processes through collaboration with cross-functional teams. First-rate computer, analysis and research skills. Specialties include achieving set targets, generating new strategies and maintaining accurate records. Possesses superior product knowledge to train and educate staff while maintaining optimal product storage and efficiency. Builds and maintains effective working relationships with internal and external customers.

Overview

10
10
years of professional experience

Work History

Quality Systems Manager

Grifols Biomat USA
02.2023 - Current
  • Advised management of quality audit non-compliance issues to facilitate improved audit compliance rates.
  • Archived quality audit reports and generated searchable index to facilitate improved report access.
  • Performed data entry tasks and verified that charts and graphs produced accurate representations of data inputs.
  • Maintained quality system documentation and updated specific documents to reflect new audit or test results.
  • Worked with users to maintain accurate quality records and supporting materials to document quality-related activities.
  • Participated in targeted customer audit initiatives and produced required documentation to support verifiable results.
  • Collaborated with internal subject matter experts to perform data reconciliations and produce credible results.
  • Scheduled and managed internal and supplier-based audits to verify compliance with document control procedures.
  • Followed quality standards and procedures to minimize errors and maximize customer satisfaction.
  • Improved quality processes for increased efficiency and effectiveness.
  • Provided observations, took measurements, and performed tests at various stages according to quality control plan.
  • Oversee Quality & Training programs within the center, including maintaining staff by recruiting, selecting, orienting, and training employees.
  • Evaluated interactions between associates and customers to assess personnel performance.

Quality Associate 2

Grifols Biomat USA
09.2021 - Current
  • Assist the Center Quality Manager in ensuring center compliance with FDA regulations
  • Designated QA Trainer
  • Frequently travel to Biomat USA Kearney Center and Brookings Center to offer QA training and assistance
  • As of June 2022, act as Anti-D Program Coordinator for BPC Lincoln Center
  • Recorded findings of inspection process, collaborating with quality team to implement corrective actions.
  • Educated employees on specific QA standards and confirmed maintenance of standards.
  • Analyzed quality and performance data to support operational decision-making.
  • Monitored product standards and quality-control programs.
  • Provided regular updates to team leadership on quality metrics by communicating consistency problems or production deficiencies.
  • Promoted adherence to quality standards by educating personnel on quality control.
  • Implemented process improvements to increase productivity in quality assurance operations.
  • Completed deviation forms and recorded findings of inspection process, collaborating with quality team members and department managers to implement procedural remedies.

Quality Associate Alternate

Grifols Biomat USA
12.2020 - Current
  • Recorded findings of inspection process, collaborating with quality team to implement corrective actions.
  • Educated employees on specific QA standards and confirmed maintenance of standards.
  • Analyzed quality and performance data to support operational decision-making.
  • Monitored product standards and quality-control programs.
  • Provided regular updates to team leadership on quality metrics by communicating consistency problems or production deficiencies.
  • Promoted adherence to quality standards by educating personnel on quality control.
  • Implemented process improvements to increase productivity in quality assurance operations.
  • Completed deviation forms and recorded findings of inspection process, collaborating with quality team members and department managers to implement procedural remedies.

Donor Floor Supervisor

Grifols Biomat USA
09.2019 - Current
  • Supervise the Pheresis production area
  • Monitor and direct an efficient flow of staff and customers to facilitate quality center operations
  • Serve as staff in production areas (including Medical Reception and Plasma Processing) as needed
  • Directly supervise personnel by giving clear and consistent instruction and direction, conducting all relevant meetings, and providing an atmosphere for open and consistent communication
  • Act as a liaison between lower staff and upper management
  • Review area records to ensure accuracy and compliance (log books, donor charts, lab or donor fees, inventory)
  • Observe employee’s performance and aid and additional training as needed
  • Schedule staff to provide adequate and safe coverage, monitor attendance, scheduling, and utilization of overtime
  • Assign a designated trainer to each new employee, monitor training process to assure adequate preparation and documentation of training program
  • Maintain up-to-date employee files with applicable training checklists, revision training, Skills Assessments, evaluations, and certification status
  • Train, mentor, & develop Team Leads for potential leadership advancement opportunities
  • Travel to other centers to assist in training as needed
  • Part of Aurora Training & Support Team that traveled to BPC in Brookings, SD in July 2020 to rollout new plasmapheresis machines
  • Currently cross-trained in all the other production areas (Medical Reception and Plasma Processing).
  • Maintained donor floor operations to include plasmapheresis donation procedures to maintain donor safety and quality of product.
  • Oversaw operation and maintenance of automated plasmapheresis machines.
  • Maintained compliance with SOP, current Good Manufacturing Procedures (cGMP) and regulatory guidelines.
  • Supervised and performed venipuncture and plasma collection.
  • Conducted performance reviews of donor floor staff.
  • Conducted routine facility inspections, identifying areas needing improvement and eliminating hazards posed to staff and residents for continued compliance with associated regulations.

Donor Floor Team Lead

Grifols Biomat USA
04.2019 - Current
  • Ensure all donor floor operations run smoothly and in a timely manner while still completing BMT duties
  • Delegate tasks to employees and act as a liaison between management, supervisor, and donor floor BMTs
  • Delegated tasks to employees to enhance productivity and workflow.
  • Assisted supervisor with feedback for employee performance evaluations.
  • Train employees on donor floor tasks and techniques
  • In June-July 2019, had the opportunity to travel to a Biotest in Russellville, AR, to assist the donor floor staff in training and phlebotomy
  • Also assisted the Specialties Coordinator in inventory and administration of red blood cell immunizations for current and new donors on the Anti-D program.

Biomedical Technician

Grifols Biomat USA
02.2018 - Current
  • Obtain plasma samples for medical testing and use via venipuncture and machine-directed plasmapheresis
  • Minimize donor pain and improve donor relationships during phlebotomy
  • Observe and follow all SOPs to maintain donor safety and adhere to FDA regulations
  • Also cross-trained in Medical Reception and Plasma Processing production areas.
  • Trained staff on proper operation of equipment as well as initial troubleshooting techniques.
  • Performed preventive maintenance for medical equipment.
  • Provided validation, inspection, repairs and maintenance on clinical biomedical equipment.
  • Maintained safe work environment and adhered to privacy regulations.
  • Labeled transfer tubes and followed exact directions for handling and storing specimens for transport.
  • Completed proper sanitation and cleaning of equipment and work areas between patients.
  • Centrifuged blood samples as outlined in clinical protocols.
  • Established and maintained positive working relationships with patients, staff and clinical personnel to build trust and camaraderie.
  • Conducted venipuncture and other CT procedures.

Microbiology Research Assistant

Nebraska Wesleyan University
10.2017 - 05.2018
  • Assisted Dr. Michael Olive, PhD in various microbiological research projects, including bacteriophage isolation from local water samples and genetic analysis (qPCR, rep-PCR, other assays) of E. coli strains for determination of nosocomial transmissionPresented findings at the Nebraska Academy of Science in May 2018.
  • Interpreted research findings and summarized data into reports.
  • Viewed and compared genomic content.
  • Designed and optimized assays.
  • Conducted experiments related to cell culture.
  • Communicated research results to individuals in industry, government and general public.

Teaching Assistant

Nebraska Wesleyan University
08.2017 - 12.2017
  • Planned activities, supervised students, graded papers, handed out class materials, and performed other assisting duties in the Anatomy & Physiology lab of Dr. Cindy Marolf, PhD
  • Assisted Dr. Marolf in cadaver dissection as well.
  • Helped with grading assignments and tests, providing constructive feedback to students based on results.
  • Assisted teachers with classroom management and document coordination to maintain positive learning environment.
  • Supported classroom activities, tutoring, and reviewing work.
  • Sanitized, restocked, and organized exam rooms and medical equipment.

Shift Supervisor

Runza Restaurants
05.2013 - 08.2017
  • Trained new employees and delegated daily tasks and responsibilities.
  • Completed store opening and closing procedures and balanced tills.
  • Resolved customer complaints and issues and offered thoughtful solutions to maintain customer satisfaction.
  • Responded to and resolved customer questions and concerns.
  • Helped store management meet standards of service and quality in daily operations.
  • Enforced company policies and regulations with employees.
  • Delivered successful training to more than 15 employees during tenure, educating on successful work processes and productivity strategies.
  • Completed cash and credit card transactions accurately using POS software.
  • Managed inventory and ordered supplies to keep location well stocked with necessary supplies.
  • Supervised ongoing daily production phases.
  • Monitored food quality and service levels to maximize kitchen and dining area performance.
  • Maintained compliance with company policies and procedures for food safety, sanitation, and quality.

Education

Master of Public Health - Public Health Administration And Policy

University of Nebraska Medical Center
Omaha, NE
05.2024

Bachelor of Science - Biology

Nebraska Wesleyan University
Lincoln, NE
05.2018

No Degree - Biotechnology

University of Nebraska At Omaha
Omaha, NE

High School Diploma -

Marian High School
Omaha, NE
05.2013

Skills

  • Quality Management System Compliance
  • Microsoft Office, including Word, PowerPoint, Excel, and Outlook
  • Risk Mitigation
  • SAP
  • MasterControl
  • ComplianceWire
  • Trackwise
  • Root Cause Analysis
  • Performance Reports
  • Internal Quality Audits
  • Continuous Process Improvement
  • Performance Monitoring
  • Budget Preparation
  • Problem-Solving Abilities
  • Document Management
  • Supplier Relationship Management
  • Statistical Analysis Skills
  • Operational Improvements
  • Team Training
  • SOP Development
  • Entry Level Programming in Javascript, HTML, & Python
  • Spanish Fluency

Timeline

Quality Systems Manager

Grifols Biomat USA
02.2023 - Current

Quality Associate 2

Grifols Biomat USA
09.2021 - Current

Quality Associate Alternate

Grifols Biomat USA
12.2020 - Current

Donor Floor Supervisor

Grifols Biomat USA
09.2019 - Current

Donor Floor Team Lead

Grifols Biomat USA
04.2019 - Current

Biomedical Technician

Grifols Biomat USA
02.2018 - Current

Microbiology Research Assistant

Nebraska Wesleyan University
10.2017 - 05.2018

Teaching Assistant

Nebraska Wesleyan University
08.2017 - 12.2017

Shift Supervisor

Runza Restaurants
05.2013 - 08.2017

Master of Public Health - Public Health Administration And Policy

University of Nebraska Medical Center

Bachelor of Science - Biology

Nebraska Wesleyan University

No Degree - Biotechnology

University of Nebraska At Omaha

High School Diploma -

Marian High School

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Nicole Butler