QA Engineer

Job Responsibilities:

• Investigate deviations and implement corrective and preventive actions.

• Create, review, or approve Change Controls for batch records, SOPs, test methods, specifications, and data sheets.

• Apply quality tools (e.g., FMEA, Fishbone, 5 Why, Risk Analysis, HFAT) in investigations and special projects.

• Analyze data to support investigations, cost savings, and continuous improvement initiatives.

• Work safely with controlled materials, following all relevant safety and quality procedures.

• Ensure compliance with current US and international quality regulations.

• Author or peer review annual product quality reports.

• Support on-site audits by regulatory agencies (e.g., FDA, Health Canada, EU authorities, TGA) as required.

• Maintain operational compliance with applicable regulatory agencies and industry standards (e.g., FDA, EU, HC, TGA, PIC/S, ISO, USP, NRC, cGMP).

Qualifications:

• Bachelor’s degree in Biology, Chemistry, or a related field preferred; equivalent work experience will be considered.

• Minimum of 3 years of relevant quality experience.

• Strong problem-solving skills, with the ability to handle conflict and make effective decisions under pressure.

• Ability to perform calculations, analyze data, and manage computer-based data entry.

• Proficiency in Microsoft Office Suite.

• Strong analytical, hands-on, and decision-making skills.

• Excellent written and verbal communication skills.

• Ability to work independently and collaboratively to meet goals and priorities.

• High energy and consistent, reliable attendance.