Algene Yandall
San Diego,CA
Summary
Dedicated Quality Lab Technician with almost three years of expertise in Quality Systems and Quality Assurance Operations. Highly skilled in utilizing advanced laboratory equipment, specialized software, and the SAP System. Demonstrated commitment to precision and excellence through rigorous testing, result interpretation, and effective implementation of quality control measures. Adept problem solver with a proven track record of delivering consistent, high-quality results. Strong attention to detail and unwavering commitment to delivering outstanding outcomes.
Overview
3
3
years of professional experience
Work History
Quality Assurance Assistant
Fate Therapeutics, A Biotech Company
04.2023 - Current
- Assist with supplier qualification processes by sending qualification questionnaires to suppliers and conducting initial reviews of completed questionnaires and supplier documentation
- Facilitate the evaluation of supplier change notifications received within the organization
- Provide support for material and product retention and archival processes, including the reconciliation of clinical drug products
- Follow up on corrective and preventive actions resulting from GxP audits
- Maintain accurate document records through scanning, logging, and filing
- Coordinate the offsite storage of documents, ensuring proper organization and staging
- Enter and manage data in Quality's internal systems during document processing
- Perform additional duties related to Document Control and Supplier Quality Management as assigned.
Quality Assurance Operations
Abzena Biotechnology Research
07.2021 - 02.2023
- Inspected raw materials to ensure compliance with industry standards and regulatory requirements
- Provided quality assurance review and support to the Quality Control and Warehouse departments
- Assumed responsibility for the disposition and qualification of raw materials, ensuring adherence to protocols, reports, method SOPs, and Certificate of Analysis (CoA) for QC Operations
- Compiled and analyzed quality control data, generating accurate reports for decision-making purposes
- Developed and updated quality standard operating procedures (SOPs) to improve process efficiency and compliance
- Implemented and enforced Good Manufacturing Practices (GMP) and current Good Manufacturing Practices CGMP standards
- Utilized software tools such as Smartsheet, Veeva, ZenQMS, and Microsoft Office Suite for effective documentation and quality management.
Quality Control Technician
Thermo Fisher Scientific Inc
05.2021 - 07.2021
- Completed precise measurements, visual inspections, and established tests to evaluate samples against predefined standards
- Followed safety protocols and cleanliness procedures to ensure compliance with agency and regulatory guidelines
- Conducted and documented first piece, in-process, and final inspections, promptly reporting any non-conformances identified
- Maintained accurate and up to date quality records and documents
- Calibrated, validated, and maintained laboratory equipment to ensure accuracy and reliability
- Conducted routine inspections of components and products, meticulously fulfilling quality assurance requirements
- Recorded lot numbers and serial numbers in the Enterprise Resource Planning (ERP) system to enable traceability of produced items
- Utilized SAP System and Microsoft Office Suite for data management and traceability purposes.
Specimen Accessioner
Helix
10.2020 - 05.2021
- Adhered to laboratory safety procedures to maintain compliance with quality control standards.
- Analyzed results using analytical software and created reports.
- Interpreted laboratory results to provide technical advice to scientists.
- Monitored and documented safety standards to verify compliance.
- Prepared samples for analysis by performing complex sample preparation tasks.
- Set and oversaw quality assurance guidelines for laboratory work.
Education
GED -
Vista Adult School
Vista, CA01.2018
Bachelor of Science - Electrical, Electronics Engineering Technologies
University of Negros-Recoletos Philippines
Philippines01.2015
Skills
- Quality Control
- Quality Improvement
- Quality Standards Knowledge
- Quality Systems - ERP, IFS, Smart Sheet, ZEN QMS, Veeva, Data Works, SAP
- GMP, cGMP, and GxP
- Quality Inspection
- Microsoft Office Suite
- Process Improvement
- Compliance Management
- Root Cause Analysis
- Data Analysis
- Documentation Management
- Initiating NCMR, CAPA, Deviation, SCARS
- Cryo Preservation/ Equipment
- Temperature Monitoring
- Inventory Management
Timeline
Quality Assurance Assistant
Fate Therapeutics, A Biotech Company
04.2023 - Current
Quality Assurance Operations
Abzena Biotechnology Research
07.2021 - 02.2023
Quality Control Technician
Thermo Fisher Scientific Inc
05.2021 - 07.2021
Specimen Accessioner
Helix
10.2020 - 05.2021
GED -
Vista Adult School
Bachelor of Science - Electrical, Electronics Engineering Technologies
University of Negros-Recoletos Philippines
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