Seeking an opportunity to continue a lifetime career at BioLife immersing myself in the culture of Takeda values. Ensuring high quality products of plasma are delivered to patients with rare diseases. Ensure a speak-up culture. Right first-time mind set. Keep it simple. Own and demonstrate commitment to quality. Exceed expectations.
Overview
6
6
years of professional experience
Work History
Quality Manager Representative
Biolife Plasma Services
02.2024 - Current
Develop and implement quality management systems to enhance operational efficiency.
Monitor all systems and activities to ensure that source plasma manufacturing is performed consistently according to current Good Manufacturing Practices (cGMP), the Shire Quality System, and other applicable regulations for a plasma center. Authorized and responsible to cease operations within the center or stop source plasma shipment(s) if product or donor safety is or may be compromised.
Review operational records to ensure they are complete, accurate and compliant with cGMP requirements.
Conduct regular audits and inspections to ensure compliance with industry standards.
Trained staff on quality assurance processes and best practices to promote consistency.
Work collaboratively with staff, peers, and management to achieve business goals.
Stay current with federal, state, local and company-specific rules, regulations, and practices.
Manager Trainee- Quality
BioLife Plasma Services
09.2023 - 02.2024
Traveling to different centers to help me pursue my career path, as it will allow me to learn and advance.
Shadowing different QMRs (Quality Management Representatives) and gaining more knowledge on the aspect of quality.
Help build leadership skills, QA office management, and professional development.
Quality Lead Technician (QLT)
BioLife Plasma Services
09.2021 - 09.2023
Trained within all positions from medical historian to sample preparation.
Regularly completed all the quality checklists, soft goods, and non-soft goods.
Conducted personnel observations of production to ensure SOP (Standard Operating Procedure) compliance of staff trained in the task.
Performed monthly system audits for control points within designated system.
Reviewed operational records and activities to ensure compliance with Good Manufacturing Procedures (GMP).
Reported errors, deficiencies, discrepancies, and observations to the management team and Quality Representative Manager (QMR).
In the absence of the Quality Representative Manager (QMR), I worked collaboratively with the management team and filled in when needed.
Maintained confidentiality of all personnel, donors, and center information.
Senior Plasma Technician (SPCT)
BioLife Plasma Services
03.2021 - 09.2021
Followed Standard Operating Procedures (SOPs) by performing all aspects of the pheresis procedure and plasma collection, including donor set-up, donor monitoring, and donor disconnect.
Performed venipuncture of donors and programming of plasmapheresis machine.
Monitor donors during donation process and manage donor reactions.
Maintained a clean work environment.
Ensured all phlebotomy supplies were stocked.
Installed, primed, and disconnected disposable sets on the plasmapheresis machines.
Performed weeklies, monthlies, and quarterlies on the plasmapheresis machines.
Registered Behavior Technician (RBT)
Hopebridge Autism Therapy Center
05.2019 - 03.2021
Worked in clinic teaching Applied Behavior Analysis (ABA) with direct supervision by a Board-Certified Behavior Analyst (BCBA).
Conducted functional behavior assessments, functional analysis, and preference assessments.
Observed, monitored, and recorded problem behaviors through accurate behavior consequence data collection, graphs, and anecdotal notes.
Monitored client progress to provide continued guidance and consistent feedback to parents.
Implemented strategies to reduce anxiety and stress levels in clients.
Educated parents to apply appropriate behavior management techniques.
Developed and implemented reinforcement systems to encourage positive behaviors.