Quality Assurance Specialist
3 weeks ago
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
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