Sonia Flecha Monge
Rockville
Summary
Detail-oriented Associate Scientist III with 3+ years of GMP experience in sterile biologics manufacturing, specializing in endotoxin testing, aseptic technique, and process optimization. Skilled in LAL testing, assay validation, CAPA investigations, and audit readiness. Cross-trained in QC, QA, and Sterility with hands-on shopfloor experience. Proficient in SAP, LIMS, and TrackWise. Bilingual in English and Spanish, with working knowledge of French and German. Committed to continuous improvement and delivering high-quality biologics through teamwork and technical excellence.
Overview
4
4
years of professional experience
1
1
Certification
Work History
Associate Scientist III, Bacteriology Department
MilliporeSigma, BioReliance Testing Services
08.2024 - Current
- Serve as team representative and lead lab initiatives focused on cross-departmental process improvement.
- Cross-trained in the Sterility, Quality Control, and Quality Assurance departments to broaden expertise across GMP workflows.
- Supported sterility testing operations to reinforce aseptic techniques and contamination control.
- In Quality Control, assisted in environmental monitoring and product testing to ensure data integrity and compliance.
- In Quality Assurance, contributed to core internal audits, SOP alignment, and assay validation processes to meet regulatory and client standards.
- Lead general change control projects for environmental isolate processes; updated SOPs and batch records.
- Created and revised critical lab documentation; authored new Phage Assay protocols.
- Direct lab site movements, interdepartmental cross-training, and work instruction development.
- Received Impact Award for driving process efficiency and compliance.
- Proficient in DOMO, Kaye LabWatch Pro, and other quality monitoring software.
- Participated in Environmental Health & Safety internship; promoted site-wide best practices.
Associate Scientist II, Bacteriology Department
MilliporeSigma, BioReliance Testing Services
09.2023 - 08.2024
- Executed GMP, GLP, and NRT testing including Mycobacterium qualification and analysis.
- Developed and updated SOPs and protocols as part of formal change control efforts.
- Supported training and mentoring of new personnel.
- Led root cause investigations, CAPAs, and C2C documentation for lab deviations.
- Initiated transition of environmental monitoring contaminants from GLP to GMP standards.
- Built and maintained master and working banks of test microorganisms.
- Appointed EHS Committee Lead for site-wide safety efforts.
Associate Scientist I, Bacteriology Department
MilliporeSigma, BioReliance Testing Services
04.2022 - 09.2023
- Conducted LAL endotoxin testing, Lysogenic/Lytic Phage assays, and microbial ID testing under GMP.
- Maintained GDocP standards via peer review, archiving, and accurate data entry.
- Acted as QC liaison for environmental monitoring sample processing.
- Operated, maintained, and calibrated lab equipment per SOPs.
- Used digital tools including WinKQCL, SAP, Oracle, LIMS, BRIQS, and Microsoft Office.
- Member of High Potential Community for leadership development.
Laboratory Technician I
Pace Analytical Services, Aerobiology Laboratory Associates
10.2021 - 04.2022
- Prepared and processed microbial samples (air/water/USP 797); performed dilutions, platings, and incubations.
- Maintained sample records, microbial banks, and ensured equipment readiness.
- Provided administrative and lab support through data entry and customer interaction.
Education
Bachelor of Science - Biology (Microbiology)
George Mason University
Fairfax, VA12.2020
Skills
- Endotoxin Testing (LAL), Phage Assays, Mycobacterium Testing
- GMP/GLP Documentation & Compliance
- Process Troubleshooting & Optimization
- Software: SAP, DOMO, Kaye LabWatch, Oracle, LIMS, TrackWise, Blue Mountain RAM
- Equipment Calibration & Maintenance
- Experimental design
- Safety processes and procedures
Websites
Certification
- Artel Pipetting Proficiency
- First Aid: CPR and AED
- CFR 40 and CFR 49 Hazardous Waste Management Generator
Languages
English
Native or Bilingual
Spanish
Native or Bilingual
French
Limited Working
German
Elementary
Timeline
Associate Scientist III, Bacteriology Department
MilliporeSigma, BioReliance Testing Services
08.2024 - Current
Associate Scientist II, Bacteriology Department
MilliporeSigma, BioReliance Testing Services
09.2023 - 08.2024
Associate Scientist I, Bacteriology Department
MilliporeSigma, BioReliance Testing Services
04.2022 - 09.2023
Laboratory Technician I
Pace Analytical Services, Aerobiology Laboratory Associates
10.2021 - 04.2022
Bachelor of Science - Biology (Microbiology)
George Mason University
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