Biotech Quality Assurance Specialist
2 weeks ago
At Biotech Desk, we are seeking a highly skilled Biotech Quality Assurance Specialist to join our team. This role plays a critical part in ensuring the quality and consistency of our biotech products.
Key Responsibilities- Product Testing: Conduct thorough testing of raw materials, intermediates, and final products to guarantee they meet quality standards.
- Method Development and Validation: Develop, validate, and implement analytical methods to assess product quality.
- Compliance Adherence: Ensure adherence to regulatory guidelines (e.g., GMP, GLP, ISO) and internal quality standards.
- Data Analysis and Interpretation: Analyze test data to identify trends, deviations, and potential issues.
- Root Cause Analysis: Investigate quality issues and implement corrective and preventive actions.
- Process Optimization: Identify opportunities to improve process efficiency and product quality.
- Method Transfer: Transfer validated methods to production and other departments.
- Equipment Calibration and Maintenance: Ensure equipment is calibrated and maintained to ensure accurate and reliable results.
- Documentation Review: Review and approve documentation related to quality control activities.
- Record Keeping: Maintain accurate and complete records of all testing activities.
- Report Generation: Prepare clear and concise reports on test results and investigation.
- Cross-Functional Collaboration: Work closely with R&D, production, and other departments to ensure product quality.
- Knowledge Sharing: Share knowledge and expertise with team members to improve overall quality.
- Training and Development: Train team members on quality control procedures and techniques.
By effectively fulfilling these objectives, our Biotech Quality Assurance Specialist contributes to the development and production of safe, effective, and high-quality biotech products.
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