Pegah Chaharmahali
STOCKTON
Summary
Clinical laboratory leader with a strong foundation in molecular diagnostics, microbiology, and regulatory compliance, complemented by an MBA that bridges science with strategic leadership. Experienced in developing and validating complex assays, writing protocols that meet CLIA, FDA, and ISO standards, and leading teams through audits, workflow redesigns, and lab-scale transformations. Known for building quality systems that are both inspection-ready and operationally efficient. With a dual focus on technical accuracy and organizational performance, I bring a systems-minded, data-driven approach to managing labs where every detail matters—from the bench to the boardroom.
Overview
11
11
years of professional experience
Work History
Molecular Pathology Manager
Yosemite Pathology Medical Group
01.2021 - Current
- Authored molecular testing protocols, including Real-Time PCR for Group B Strep and Real-Time Transcription-Mediated Amplification (TMA) assays for COVID-19, Candida species group, Trichomonas vaginalis, HPV, Chlamydia trachomatis, Neisseria gonorrhoeae, Mycoplasma genitalium, and HSV 1 & 2.
- Led laboratory team in maintaining CLIA-compliant safety standards and protocols.
- Reduced accessioning errors by 60% through implementation of new quality control measures and policy changes.
- Partnered with cross-functional teams to develop and implement standard operating procedures, improving workflow efficiency and productivity.
- Analyzed clinical data trends, including test positivity rates and Levey-Jennings charts, to validate new methodologies and uphold quality benchmarks.
- Ensured adherence to Good Clinical Practices (GCP) to maintain high standards of accuracy and reliability in diagnostic testing.
Quality Assurance Lead Microbiologist
Diamond Pet Foods
02.2015 - 12.2020
- Developed and implemented a comprehensive quality assurance program for the microbiology laboratory, resulting in 100% compliance with all regulatory inspections.
- Led a team of seven microbiologists in executing analytical testing on raw materials, finished products, and environmental samples, ensuring strict adherence to quality standards.
- Directed cross-functional collaboration to resolve quality deviations, applying root cause analysis and corrective/preventive action (CAPA) strategies to strengthen systems.
- Delivered accurate and timely test reports to the corporate office, ensuring alignment with ISO, FDA, and internal compliance standards.
- Supported FDA, ISO, and cGMP audits and inspections, achieving a 100% certification success rate and reinforcing regulatory readiness.
- Standardized lab testing procedures to meet ISO regulations, contributing directly to the successful acquisition and maintenance of ISO certifications.
- Conducted internal audits to identify process inefficiencies and led implementation of corrective action plans to drive continuous improvement.
- Assessed and ensured international product export compliance by interpreting foreign regulatory frameworks and trade requirements.
- Designed, authored, and updated microbiological and molecular protocols—including plating, PCR, ELISA, and immunoassays—to optimize lab methodologies.
- Authored and signed off on Certificates of Analysis (COAs) for batch-specific products, ensuring accuracy, regulatory integrity, and documentation completeness.
Quality Assurance Analyst
Ingredion
06.2014 - 01.2015
- Led a cost-reduction initiative that lowered HFCS-55 production expenses by 40%, significantly improving operational efficiency.
- Conducted quality and performance assessments to ensure compliance with industry standards and regulations.
- Employed analytical and problem-solving skills to identify areas of improvement in the production process.
Education
MBA - Business Administration And Management
University of California, Davis
Davis, CA06-2025
Biological Sciences
University of The Pacific
Stockton, CA12-2014
Biological Sciences
University of California, Davis
Davis, CA12-2009
Graduate Certificate - Bioinformatics
University of California, San Diego
La Jolla, CA06-2020
Skills
- Cross-Functional Team Leadership
- Process Optimization & Workflow Redesign
- Strategic Planning & Cost Reduction
- Performance Management & Staff Development
- Change Management
- Root Cause Analysis & CAPA Implementation
- Training & Mentorship
- Project Management
- Communication & Stakeholder Alignment
- Molecular Diagnostics (PCR, TMA, ELISA, Immunoassays)
- Quality Assurance & Control (ISO, FDA, CLIA, cGMP)
- SOP Development & Implementation
- Clinical Data Analysis (Levey-Jennings, Positivity Trends)
- Method Validation & Instrument Comparison
Timeline
Molecular Pathology Manager
Yosemite Pathology Medical Group
01.2021 - Current
Quality Assurance Lead Microbiologist
Diamond Pet Foods
02.2015 - 12.2020
Quality Assurance Analyst
Ingredion
06.2014 - 01.2015
MBA - Business Administration And Management
University of California, Davis
Biological Sciences
University of The Pacific
Biological Sciences
University of California, Davis
Graduate Certificate - Bioinformatics
University of California, San Diego
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