Linda A. Salas Meza

About Linda A. Salas Meza

With nearly eight years of industry and academic experience, I am a bilingual microbiologist specializing in RT PCR and Kinetic Endotoxin, among other QC testing. During my time in the industry I have reviewed and tested samples to support cGMP and non-GMP projects, ensuring product safety and quality.I am a self-directed professional who values the communities I inhabit and strive to build my team up by organizing team-building activities, bridging departmental training gaps, and mentoring my peers.

Experience

1. Quality Control Associate

   Amgen

   Mar 2024 — Present · NC, US

   Acted as Subject-Matter Expert to determine team readiness for site Method Transfer of PCR and Endotoxin.Tested and qualified RT-PCR runs for products in efforts to support site-readiness.Mentored and trained personnel on microbiological techniques and data review, including Kinetic Endotoxin, Bioburden (Water & Product), Growth Promotion, and Biological Indicator Testing.Provided operational and technical information supporting Data Integrity Assessments of three Critical Equipment (QuantStudio 7, Kinetic Plate Reader, and MCS).Authored, revised, and reviewed 20+ documents, including but not limited to SOPs, training documents, and forms supporting microbiological programs e.g. authored Microbiology Identification Program for NC.Collaborated with SMEs on multi-site documents to update multi-site documents and move towards digitalization of documentation workflows.Reviewed the changes to the revision of multi-site electronic documentation for Conductivity to match current specifications.Owned and managed minor deviation investigations during start-up activitiesCoordinated vendor equipment installation and operation qualification activities to support QC laboratory start up activitiesFacilitated PCR training at ANC by coordinating with internal departments and other Amgen sites to secure instrument and inventory access for trainers and trainees.Approved 27% of batches for Conductivity, Endotoxin, TOC, and Bioburden during WFI PQ and routine testing.Coordinated the receipt and test of STAT Biological Indicators with manufacturing personnel during start-up activities.Represented ANC during the PCR Network meeting to discuss start-up readiness.Managed PCR laboratory, e.g, consumables and equipment inventory, equipment IOQs, and Procedure updates.Recognized as the Point of Contact for implementing the PCR harmonization programs.

Education

• North Carolina State University

  Master of Science - M.Sc., Microbiology, Biorremediation

  2017 — 2020

• Tecnológico de Monterrey

  Bachelor of Science (B.S.), Biotechnology

  2011 — 2016

Skills

• Microsoft Office
• Leadership
• Microbiology
• Matlab
• Public Speaking
• English
• Project Management
• Teamwork
• Molecular Biology
• Team Leadership
• Strategic Planning
• Research
• Microsoft Excel