QA Engineer

Job Responsibilities 

• Lead investigations into quality events and nonconformances; determine root cause and implement appropriate corrective and preventive actions.

• Prepare, review, and process change control documentation related to manufacturing records, procedures, analytical methods, specifications, and controlled documents.

• Apply structured problem-solving and risk assessment tools (e.g., failure mode analysis, cause-and-effect analysis, 5 Why methodology, and other risk evaluation techniques) to support investigations and improvement projects.

• Analyze operational and quality data to support investigations, cost reduction initiatives, and continuous process improvements.

• Perform duties in environments involving controlled or regulated materials, ensuring adherence to all applicable handling requirements.

• Promote and maintain a compliant and safe work environment through training participation, procedural adherence, and alignment with established safety and quality standards.

• Stay current with domestic and international regulatory requirements and industry standards applicable to pharmaceutical and/or regulated manufacturing environments.

• Author and/or peer review periodic product quality reports and related documentation.

• Provide support during regulatory inspections and audits as needed.

• Maintain compliance with applicable global regulatory frameworks and quality standards, including GMP and other governing bodies relevant to regulated manufacturing

Qualifications

• Bachelor’s degree in a scientific discipline such as life sciences, chemistry, or a related field preferred; equivalent combination of education and relevant experience will be considered.

• Minimum of three years of experience in a regulated or quality-focused environment.

• Demonstrated ability to assess situations, resolve issues, manage conflict, and make sound decisions in time-sensitive settings.

• Comfortable performing mathematical calculations ranging from basic to advanced levels and interpreting data to support decision-making.

• Proficient in standard business software applications, including word processing, spreadsheets, and presentation tools.

• Strong computer literacy, including experience with data entry systems and electronic documentation platforms.

• Solid analytical, hands-on troubleshooting, and critical thinking capabilities.

• Effective written and verbal communication skills with attention to clarity and detail.

• Ability to work both independently and collaboratively to meet organizational objectives and deadlines.

• Dependable, self-motivated, and capable of maintaining consistent performance in a fast-paced environment.