Anne Perez
Charleston
Summary
Quality assurance professional known for high standards and consistent results. Extensive experience in identifying and resolving quality issues to maintain top-tier product standards. Reliable team player with focus on collaboration and adapting to evolving project needs.
Overview
7
7
years of professional experience
1
1
Certification
Work History
Quality Assurance Specialist
The Blood Connection
06.2023 - Current
- Manages retraining and competency evaluation needs to prepare staff for current good manufacturing practices and key quality center-wide policies
- Reviews the performance of validation plans and ensures adequate performance of processes and/or equipment
- Reviews donor screening process for accuracy and directs blood products to destruction if Standard Operating Procedure are not followed and reviewed
Medical Screener, Team Lead
Octapharma Plasma
11.2022 - 06.2023
- Ensured patient privacy and confidentiality while maintaining meticulous record-keeping practices.
- Provided exceptional customer service, responding to inquiries regarding testing procedures or follow-up appointments as needed.
- Influenced positive change within the organization through strategic thinking, innovation, problem-solving abilities, and consistent leadership style.
- Obtained patient vitals such as height, weight and blood pressure, utilized finger sticks and screening equipment to check hematocrit and protein levels.
Clinical Researcher
Medical University of South Carolina
04.2022 - 11.2022
- Assist in IRB submissions for Continuing Reviews, DSMB reports, Protocol Deviations, and Protocol Amendments
- Organize regulatory records and filing source materials in preparation for site visits and study closing, including FDA audits
- Biological specimen processing including but not limited to centrifugation, separation of plasma and serum from whole blood samples
Manager
Skyzone
07.2021 - 04.2022
- Teach behavioral and emotional management with self-regulation skills and activities
- Create and manage schedule of activities and encourage children to engage in safe and mentally stimulating play
- Improved program efficiency by streamlining processes and implementing time-saving solutions.
- Enhanced project visibility with regular status updates, leading to increased stakeholder engagement.
Clinical Lab Associate II
Medical University of South Carolina
03.2020 - 11.2021
- Maintain FDA regulatory, protocol compliance with IRB, while communicating with project manager, study monitors, and study personnel
- Pre-analytical process of 15,000 specimens daily for clinical testing
- Practice informed consent documents and queries in Data Management, and drug/device accountability
Quality Assurance, Lab Technician
Octapharma Plasma
07.2018 - 03.2020
- Measure vitals and process biological specimen including but not limited to centrifugation, separation of plasma and serum from whole blood samples
- Monitor compliance and report deviations to Standard Operating Procedure, current Good Manufacturing Procedures, and deviation control
Education
Bachelor of Arts and Sciences - Biology, Gender Studies
University of South Carolina
Columbia, South Carolina12.2017
Skills
- Detail-oriented
- Problem-solving skills
- Quality assurance
- Relationship building
Certification
- CITI Certification for Human Subjects, Biomedical Research, and Good Clinical Practice,
- CITI Certification for Shipping Hazard for Infectious Specimens
- CITI Certification for Shipping Hazard for Non-Infectious Specimens
- NexSys PCS Tech Tools & Support, current Good Manufacturing Practices, and Quality Control Management Certification
Timeline
Quality Assurance Specialist
The Blood Connection
06.2023 - Current
Medical Screener, Team Lead
Octapharma Plasma
11.2022 - 06.2023
Clinical Researcher
Medical University of South Carolina
04.2022 - 11.2022
Manager
Skyzone
07.2021 - 04.2022
Clinical Lab Associate II
Medical University of South Carolina
03.2020 - 11.2021
Quality Assurance, Lab Technician
Octapharma Plasma
07.2018 - 03.2020
- CITI Certification for Human Subjects, Biomedical Research, and Good Clinical Practice,
- CITI Certification for Shipping Hazard for Infectious Specimens
- CITI Certification for Shipping Hazard for Non-Infectious Specimens
- NexSys PCS Tech Tools & Support, current Good Manufacturing Practices, and Quality Control Management Certification
Bachelor of Arts and Sciences - Biology, Gender Studies
University of South Carolina
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