Quality Assurance Engineer

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