HAMZAH ALHAMADANI
San Diego,CA
Summary
Experienced Quality Control Analyst with 6+ years in QA/QC across four medical industries. Expertise in developing protocols, conducting material and product testing, and microscope analysis. Bilingual in Arabic and English, with a strong focus on enhancing manufacturing quality.
Overview
14
14
years of professional experience
Work History
QC Lab Lead Technician
Becton Dickinson Biosciences
San Diego, CA
11.2020 - Current
- Conduct routine final inspection testing for BD Veritor COVID-19 At-Home kits (negative extraction, Standards 1 & 3, negative standard) to ensure product release using required instrumentation.
- Timely testing of products to support manufacturing and product release schedules.
- Perform chemical and reagent inspections prior to R&D lab usage.
- Inspect bottled products, components, and kits for correct volume, labeling, material numbers, batch numbers, and storage temperatures.
- Review packaging batch records to verify accuracy of Technical Data Sheets and any required inserts.
- Ensure dilution, bottling, and packaging processes meet specifications before product release to finished Goods or Inventory Control.
- Monitor QA Freezers’ temperature and perform other QA duties as needed.
- Demonstrate in-depth knowledge of GMPs, ensuring accurate completion of testing paperwork.
- Conduct additional testing for Out-of-Specification (OOS) investigations as directed by Quality Management.
- Perform temperature Excursion and Stability tests, risk analyses, and result evaluations.
- Handle customer complaints, conduct technical investigations, and report data via the TrackWise system.
- Monitored and managed lab equipment like freezers, temperature data loggers, and centrifuges using the Blue Mountain BMRAM system to ensure optimal performance and compliance.
Quality Control Technician
Philips Healthcare
Carlsbad, CA
05.2020 - 12.2020
- Performs visual, dimensional, and functional testing of raw materials, subassemblies, and finished devices according to approved procedures and specifications.
- Accurately document results of inspection and testing following good documentation practices.
- Assist in review of manufacturing batch records/traveler and inspection reports.
- Assist in RMA processing and release.
- Participate in quality audits (internal, FDA, ISO, etc.)
- Provide input for continuous improvement of inspection procedures and processes.
- Ensure training is current.
- Assist in preparing quality records for archiving, including scanning.
Lead QC Inspector
Sendx Medical, Inc
Carlsbad, CA
07.2019 - 06.2020
- Test with ABL80 FLEX CO-OX analyzer providing blood gas, electrolytes, glucose, and CO-oximetry parameters with all advantages of a compact system, including simplicity and reliability
- Experience in quality control ensures ABL80 FLEX CO-OX analyzer reliability of testing performed at point of care and documents regulatory compliance.
- Performs Receiving Inspection activities according to SOPs and other approved Work instructions.
- Performs final QA releases according to SOPs and other approved work instructions.
- Investigates/analyzes problems identified and recommends appropriate follow-up to value stream supervisors and QA Engineers.
- Prioritize and communicate with VSM teams and Shipping on daily QA releases.
- Perform training for Receiving Inspection and other QC areas.
Quality Assurance Technician
MPC Healthcare, AE
Dubai, AE
01.2013 - 11.2014
- Completed recordkeeping, filing, and data entry duties.
- Performed technical and quality systems audits of laboratory.
- Performed routine preventive maintenance on equipment parts and materials.
- Diagnosed and reported malfunctions of technical equipment.
Quality Assurance Technician
Saint Raphael Hospital
02.2011 - 07.2012
- Evaluated samples against standards by completing measurements, visual inspections, and other tests.
- Performed thorough inspections of incoming materials and outgoing products.
- Developed quality assurance plans by conducting hazard analyses, identifying critical control points, and establishing required limits.
- Inspected, verified, and documented quantifiable characteristics of finished goods by comparing them against customer specifications and company quality standards.
- Routinely tested products to align temperature, specifications, and ingredient levels with best practices and quality standards.
- Analyzed test data to determine performance and reliability of materials
Education
Bachelor of Arts -
California State University - San Marcos
San Marcos, CA01-2024
Bachelor of Science -
Baghdad University
Baghdad01-2013
Skills
- Over five years of quality experience in medical device industry, including BD Veritor Plus Analyzer, Philips V60 Ventilator, Radiometer ABL-90, ABL 800, and ABL 80 CO-OX Flex blood Gas analyzers
- Experience testing COVID-19 At-Home samples And reports analyzed data using the Scan well health app
- Ability to perform Out-Of-Specification (OOS) And investigates root cause of failure, Risk, and corrective action
- Experience testing with BD products such as SARS-COVID-19 At-Home, and FlU AB antigen test
- Experience using laboratory and quality management systems Track-wise & SAP data entry
- Experience test investigation BD product Kit complaints returned by the customer using Track-wise And reports data results
- Prepare chemical solutions for products or processes following standardized formulas
- Experience installing software & Final Testing medical devices such as (Respironics V60 ventilator) at Philips Healthcare
- Conduct chemical or physical laboratory formulations and tests to assist scientists in making qualitative or quantitative analyses of solids, liquids, or other materials
- Assists in developing quality systems & make recommendations for improvements to existing Quality systems
- Experience in QSR FDA or ISO/GMP Regulated production environment
- Experience with Continuous Improvement, Problem Analysis, Root Cause Investigation
- Knowledge of Quality sampling plans and ability to read and help with AQL inspection plans
- Excellent experience in Microsoft Office and use of office equipment
Timeline
QC Lab Lead Technician
Becton Dickinson Biosciences
11.2020 - Current
Quality Control Technician
Philips Healthcare
05.2020 - 12.2020
Lead QC Inspector
Sendx Medical, Inc
07.2019 - 06.2020
Quality Assurance Technician
MPC Healthcare, AE
01.2013 - 11.2014
Quality Assurance Technician
Saint Raphael Hospital
02.2011 - 07.2012
Bachelor of Arts -
California State University - San Marcos
Bachelor of Science -
Baghdad University
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