Open To Work
Alexander Ligon
Mountain View
Summary
Quality focused and adaptable professional with a proactive attitude and the ability to learn quickly. Strong work ethic and effective communication skills. Eager to contribute to a dynamic team within a cGMP environment and support organizational goals.
Overview
5
5
years of professional experience
Work History
QC Scientist – Quality Control
Specific Diagnostics (a Biomerieux company)
San Jose
01.2023 - Current
- Conducts routine QC testing of incoming raw material, finished goods, and stability products.
- Manage QC testing schedule alongside production schedule to ensure timely closure of work orders.
- Document results, issues, and other relevant information using good documentation practices (GDP) under the site Quality Management System.
- Reviews production batch records and QC test results for accuracy, completeness, and GDP.
- Supports and executes protocols for analytical and microbiological test methods and aids in the transfer of methods to QC.
- Analyzes, prepares, and communicates data findings, trends, non-conformances, and deviations.
- Assists as needed with investigations to determine root cause of non-conformances using TrackWise Digital.
- Maintain lab equipment compliance by ensuring preventative maintenance and calibrations are completed on time.
- Supports environmental monitoring of production spaces.
- Performs subculture of organisms required for testing, ensuring organism availability.
- Run instrumentation including, but not limited to UV-Vis and FTIR spectrophotometers, and microbiological diagnostic equipment.
- Maintains inventory and orders lab supplies as needed.
- Practices good lab safety according to OSHA/EHS regulations and Good Laboratory Practice (GLP), as well as other applicable regulations.
- Updates QC methods, procedures and/or specifications as needed.
- Ensures cleanliness of QC laboratory
- Trains new team members as needed.
- Biomerieux.com
Microbiologist - R&D, Verification & Validation
Specific Diagnostics (a Biomerieux company)
San Jose
01.2022 - 01.2023
- Provide guidance to test methods, equipment acquisition, sample plan definition, and validation development.
- Processing and testing biological specimen samples using aseptic technique and lab safety protocols.
- Perform a variety of standardized tests within microbiology department including AST, BMD, VITEK MS Prime, VITEK 2, and BIOMIC.
- Perform microbiological examinations for the detection and identification of pathogenic bacteria from blood cultures.
- Working independently and as a member of a cross-functional team to support microbiology research and development.
- Authoring and reviewing protocols, reports, SOPs, work instructions, and other product-related documents.
- Performs routine lab maintenance.
- Specificdx.com
Quality Control Specialist
Synthego
Redwood City
01.2021 - 01.2022
- Provide guidance to test methods, equipment acquisition, sample plan definition, and validation development.
- Provide guidance and decisions on product development activities to ensure compliance with internal procedures and applicable regulatory or international standards.
- Document, analyze, and interpret QC and experimental data.
- Perform EM sampling and testing of GMP rooms.
- Conduct and Review monthly EM Trending.
- Responds to internal and external customer inquiries and requests as relevant to product quality or integrity.
- Investigates customer complaints and obtains data for customer inquiries that are relevant to QC.
- Provides troubleshooting support for analytical equipment (LC-MS, HPLC, GC).
- Management of contract testing labs for in-process and final release assays.
- Recommends testing for manufacturing-related non-conformances and CAPAs using Arena and Qualio Document Management systems.
- Conduct microbiological testing such as bioburden, endotoxin, TOC, and Conductivity.
- Conduct routine chemistry testing of raw materials, in-process, final and stability.
- Provide guidance for Market Specification, Functional Specification, Design Verification, Design Validation, Test Method Validation, Failure Mode Effects Analyses, and Design Reviews.
- Synthego.com
Education
Herbal Academy Certified Herbalist -
Herbal Academy
Bachelor of Science - Biology
Skills
- Quality control testing
- Analytical method validation
- Microbiological testing
- Document management
- Laboratory instrumentation
- Regulatory compliance
- Cross-functional collaboration
- Data analysis
- Troubleshooting techniques
- Environmental monitoring
- Effective communication
- Team training
- Lab safety practices
- Problem solving
- Attention to detail
- Project management
- Team leadership
- Training and mentoring
- ISO 9001
- Process validation
- ISO standards
- Equipment calibration
- QC planning
Work Preference
Job Search Status
Open to workWork Type
Full TimeContract WorkSalary Range
$95000/yr - $200000/yrTimeline
QC Scientist – Quality Control
Specific Diagnostics (a Biomerieux company)
01.2023 - Current
Microbiologist - R&D, Verification & Validation
Specific Diagnostics (a Biomerieux company)
01.2022 - 01.2023
Quality Control Specialist
Synthego
01.2021 - 01.2022
Herbal Academy Certified Herbalist -
Herbal Academy