Job Description
Job Title: Quality Control Specialist Trainer (Microbiology + Chemistry)
Experience Required: 8+ Years in Quality Control (Pharma / Biopharma / Medical Devices)
Location: Remote
Responsibilities
Perform end-to-end quality control testing of pharmaceutical/biological products, covering both microbiological and chemical analysis.
Conduct microbiological assays including sterility testing, microbial limits, endotoxin testing, and environmental monitoring.
Execute chemical testing of raw materials, intermediates, and finished products using techniques such as HPLC, GC, UV, and wet chemistry.
Maintain and calibrate laboratory instruments, ensuring accuracy and reliability of test results.
Review, document, and interpret QC data in compliance with GDP and regulatory standards (USFDA, EMA, WHO, etc.).
Support method validation, stability testing, and release activities for raw materials and finished goods.
Adhere to GLP, GMP, and safety practices while performing laboratory operations.
Investigate OOS/OOT results, deviations, and support CAPA implementation.
Train and mentor junior QC analysts in both microbiology and chemistry techniques.
Key Skills
Microbiological testing (sterility, endotoxin, microbial limits, EM)
Analytical techniques (HPLC, GC, UV, FTIR, titrations, wet chemistry)
Knowledge of GMP, GLP, GDP, and regulatory compliance
Data integrity and technical documentation
Instrument calibration and troubleshooting
Root cause analysis and problem-solving
Training and mentoring ability
