Kimia Masiha

Quality Control Microbiologist with hands-on experience at three pharmaceutical manufacturers, specializing in microbial limit testing, environmental monitoring, and contamination control. Validated test methods, led Out-of-Specification (OOS) investigations with Quality Assurance, and served as the QC microbiology lead for a Sanofi product line held to multinational standards. Works to cGMP, GDP, USP, and International Pharmacopoeia requirements and keeps the lab ready for inspection at any time.

Currently completing a PhD in Microbiology.

Quality Control Microbiologist at Dr. Abidi Pharmaceuticals (2024-06 – 2025-12)

• Tested more than 100 samples a month across raw materials, in-process bulk, and finished product, including Microbial Limit Testing (MLT), bioburden, and water system analysis, all to cGMP, GDP, and USP requirements
• Validated microbial test methods and new testing protocols on schedule, raising lab throughput by 15%
• Served as the QC microbiology lead for the Sanofi product line, meeting the partner's multinational quality, safety, and compliance requirements
• Carried out Microbiological Risk Assessments (MRA) for non-specified microorganisms, high bioburden results, and alert and action level excursions
• Worked with QA and Regulatory to run root cause analysis and CAPA on OOS results, contributing to a 100% compliance record in national regulatory audits
• Operated, calibrated, and maintained autoclaves, incubators, and biosafety cabinets with zero operational downtime

Quality Control Microbiologist (Internship) at Soha Pharmaceutical Company (2023-04 – 2023-09)

• Supported daily QC operations under cGMP, including media preparation, growth promotion testing, and routine lab upkeep
• Assisted senior microbiologists with cleanroom environmental monitoring and bioburden testing, recording all data to GDP standards

Quality Control Microbiologist at Nouyan Negin Parsian (2021-03 – 2022-04)

Medical Equipment Manufacturing

• Managed daily MLT workflows for raw materials and finished products, turning results around quickly to keep production on schedule
• Isolated and identified recovered organisms to genus and species level to build the facility's contamination profile and trend environmental data
• Wrote, reviewed, and updated more than 10 Standard Operating Procedures (SOPs) for microbiology workflows, improving consistency and audit readiness

PhD in Microbiology (ABD)– Islamic Azad University (IAU), Iran (2021)

Master of Science (M.Sc.) in Microbiology – Islamic Azad University (IAU), Iran (2020)

Bachelor of Science (B.Sc.) in Microbiology – Islamic Azad University (IAU), Iran (2017)