Quality Assurance Engineer

Overview

Consultant - Engineering Specialist | Harba Solutions Indianapolis

Compensation

Base pay range : $35.00 / hr - $37.00 / hr

Note : This range is provided by Harba Solutions Inc.. Your actual pay will be based on your skills and experience — talk with your recruiter to learn more.

Responsibilities

• Lead and support investigations of exceptions and deviations, identifying and implementing effective corrective actions.
• Review and / or generate change controls related to Batch Records, SOPs, Test Methods, Specifications, and Data Sheets.
• Apply quality tools such as FMEA, fishbone diagrams, 5 Whys, Risk Analysis, and HFAT to investigations and project work.
• Analyze data to support investigations, cost-saving efforts, and continuous improvement initiatives.
• Work with radioactive materials while adhering to all safety protocols.
• Promote a safe and compliant work environment through training, awareness, and adherence to safety and quality procedures.
• Stay current on U.S. and international quality regulations and standards.
• Author or perform peer reviews of Annual Product Quality Reviews (APQRs).
• Provide support during regulatory inspections (e.g., FDA, Health Canada, TGA, EU) as needed.
• Ensure operational compliance with applicable regulatory requirements, including FDA, EU, HC, TGA, PIC / S, ISO, USP, NRC, and cGMP standards.

Qualifications

Eligibility and Benefits

Inferred from the description for this job : Medical insurance, Vision insurance, 401(k).

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