Quality Assurance Engineer
2 weeks ago
We are looking for candidates with professional, hands-on experience in an analytical wet-chemistry lab. A Bachelor's degree in Science or Engineering is preferred, but other degrees may be considered.
Job Description:
This role involves performing selected quality control testing activities, which may include:
- Raw Materials & Product Testing: Conduct raw materials, in-process, finished product, and stability testing in compliance with standard operating procedures (SOPs).
- Environmental Monitoring & Sampling: Collect and test environmental monitoring and utility samples (e.g., compressed air, gases, water for injection, steam).
- Documentation: Complete and maintain accurate documentation for testing procedures, including data capture forms, equipment logbooks, and inventory forms.
- Equipment Troubleshooting: Identify and resolve equipment problems as needed.
- Data Entry & Reporting: Input data for compliance evaluations and report any abnormalities in results.
- SOP & cGMP Compliance: Follow all SOPs and ensure compliance with current Good Manufacturing Practices (cGMPs).
- Validation Support: Assist in the preparation of validation protocols, execute experiments, and provide data for validation reports.
- Problem Solving: Apply critical thinking and scientific methods to address issues as they arise.
- Technical Expertise: Handle problems requiring in-depth knowledge of scientific methods and techniques.
- Tech Transfer & Studies: Execute technology transfer and other studies related to laboratory test methods.
- Documentation Review: Perform review of logbooks, GQCLIMS, and MODA records
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