Detail-oriented and accurate Quality Control Analyst ,Experienced in Handling Biological and chemical materials. Experienced working in Clean Room with GMP and GDP compliant Environment. Experienced in fast-paced environment ,Strong Positive attitude towards work / Self motivated and team Player, Good Written and Oral communication Skills , Always willing to learn. Interested in potential growth, interest in career longevity in a facility. Willingness to take new responsibilities and expand knowledge.
Overview
20
20
years of professional experience
Work History
Sr. IQA Inspector
Abbott Vascular Inc ( Hiregenics Agency)
3885 Bohannon Dr, Menlo Park, CA 94025
12.2022 - Current
Inspects and approves incoming materials by confirming specifications, conducting visual and measurement tests, and rejecting and returning unacceptable materials.
Parts for inspection include mechanical, chemical, printed material and potential bio-hazards components.
Measure product using Ruler, Calipers, Pin Gauge, Micrometers and other Measuring Instruments.
Operate Electronic Inspection equipment and Software
Measure Raw materials Using ROI Optical Measuring System and MicroVu Vertex Measuring System
Keeps measurement equipment operating by following operating instructions and calibration requirements, and calling for repairs.
Maintains safe and healthy work environment by following standards and procedures, and complying with legal regulations.
Ability to read Blueprints, Drawings and Diagram
Performed Inspections for Raw Materials using Acceptance Quality Limit (AQL)
Measure Raw Materials using Keyence 3D laser Microscope
Measure Raw materials using Glee Bar Machine
QUALITY CONTROL ANALYST
CEPHEID CORP
Newark, CA
07.2022 - 10.2022
Performs and documents laboratory testing of finished product per procedure
Support finished product testing activities in accordance with GMP standards and
FDA/ISO regulations
Conduct data analysis according to established methods and product specifications
Performs laboratory and equipment maintenance / calibration activities as
Instructed Maintains Laboratory reagent and control material inventories
Responsible for instrument maintenance, daily Lab maintenance, productivity tracking, and up dating SOP binders with correct and relevant SOPs
Participate in test method validation activities
Performs other duties as assigned or requested
Ability to clearly communicate and updates on progress status of sample processed complete
ROTOR QC TECHNICIAN
ZOETIS INC
Whipple, Union City, CA
04.2021 - 07.2022
Test Rotors on Instrument according to Procedures
Performed In-Line Testing According to Standard Operating Procedure
Process and save data using PC computer and related tools
Analyzed and Troubleshoot issues during production to ensure rotor production quality
Track and trend Production failure modes.
Understand Good Manufacturing Practice (GMP) and Good Documentation Practice (GDP)
Perform Line Clearance and Cleaning Verification per standard Operating Procedure
Inspected Raw Materials and Finished Products to verify quality and disposed items that did not meet safety requirements.
Performed Packaging and final Inspection according to procedures
Helped uncover and fix production problems in order to reduce overall defect rates.
Beads Inspection Certified
Weld Inspection Certified
Perform and Review Batch Record
Assembler 2
ZOETIS INC, (Adecco)
Whipple, Union City, CA
04.2003 - 01.2021
Medical Device Assembler , performed Entry level Rotor Production Processes such as Material Handling,packaging, loading and unloading semi- automated equipment
Understand Good Manufacturing Practice (GMP) and Good Documentation
Certified Beads Inspection
Certified Weld Inspection
Cover Welding
PRODUCTION BUILDER/MEDICAL DEVICE ASSEMBLER
PENUMBRA INC
Harbor Parkway Alameda, CA
04.2018 - 07.2018
Performed a wide variety of task and processed that are required to build, assemble, inspect products in a controlled manufacturing environment using microscope and small -handled tools
Maintain Compliance with GMP, Penumbra's Quality Manual, Standard
Operating Procedures, Work Instructions and other company Standard.
Admin/ Purchaser
Gascon Auto, Repair Services
08.2014 - 02.2018
Promoting and Marketing Business
Purchasing
Handling Customers
Handling Administrative Work
Project Admin
Techkon Pte Ltd
06.2012 - 01.2013
Handle Administrative Work
Site Visit for Project Inspection
Organizing Project Progress Report (Weekly and Monthly)
Assist Accounting Work as per companies account status
Marketing - Assist project potential buyers
Responsible to all buyers concerned and needs.
Professional Sales Executive
SEL- J PHARMACEUTICALS & DISTRIBUTOR
11.2008 - 04.2012
Achievement of assigned sales objectives
Promotional and detailing of products among Medical Doctors
Implement of business- building activities
Good Performance during Training
Accomplishment of administrative functions
Medical Representative
Healthcare Pharmaceuticals and Distributor
01.2008 - 10.2008
Achievement of assigned sales objectives
Promotional and detailing of products among Medical Doctors
Implement of business- building activities
Good Performance during Training
Accomplishment of administrative functions
Medical Representative
Hovid Pharmaceuticals Inc
09.2006 - 01.2008
Achievement of assigned sales objectives
Promotional and detailing of products among Medical Doctors
Implement of business- building activities
Good Performance during Training
Accomplishment of administrative functions
Education
Bachelor of Science - COMMERCE MAJOR IN MANAGEMENT ACCOUNTING
Holy Trinity College
Philippines
03.2004
Skills
Computer Skills and Software Used
Microsoft Excel, Word, Power point
GenXpert Software, Camstar, Assay Kit, Mini Tab, Agile, Veeva Vault, IMES, Infinity Quality System
Viewer Application
Multifile Analyzer
Timeline
Sr. IQA Inspector
Abbott Vascular Inc ( Hiregenics Agency)
12.2022 - Current
QUALITY CONTROL ANALYST
CEPHEID CORP
07.2022 - 10.2022
ROTOR QC TECHNICIAN
ZOETIS INC
04.2021 - 07.2022
PRODUCTION BUILDER/MEDICAL DEVICE ASSEMBLER
PENUMBRA INC
04.2018 - 07.2018
Admin/ Purchaser
Gascon Auto, Repair Services
08.2014 - 02.2018
Project Admin
Techkon Pte Ltd
06.2012 - 01.2013
Professional Sales Executive
SEL- J PHARMACEUTICALS & DISTRIBUTOR
11.2008 - 04.2012
Medical Representative
Healthcare Pharmaceuticals and Distributor
01.2008 - 10.2008
Medical Representative
Hovid Pharmaceuticals Inc
09.2006 - 01.2008
Assembler 2
ZOETIS INC, (Adecco)
04.2003 - 01.2021
Bachelor of Science - COMMERCE MAJOR IN MANAGEMENT ACCOUNTING