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Quality Assurance Specialist
Job in
Indianapolis, Marion County, Indiana, 46262, USA
Listed on 2026-01-12
Listing for:
Harba Solutions Inc.
Full Time
position Listed on 2026-01-12
Job specializations:
-
Quality Assurance - QA/QC
Data Analyst -
Healthcare
Data Scientist
Job Description & How to Apply Below
Job Responsibilities
- Conduct quality assurance audits and inspections of manufacturing processes, facilities, and documentation.
- Review batch records, SOPs, and quality documentation to ensure compliance with GMP and regulatory standards.
- Investigate deviations, non-conformances, and customer complaints; support root cause analysis and CAPA (Corrective and Preventive Action) implementation.
- Collaborate with cross-functional teams (Manufacturing, Engineering, Regulatory Affairs) to resolve quality issues and implement improvements.
- Support validation activities and maintain QA records in compliance with company and regulatory requirements.
- Participate in regulatory inspections and internal audits as needed.
- Assist in the development and revision of quality policies, procedures, and training materials.
- Bachelor’s degree in Life Sciences, Chemistry, Biology, or related field.
- 2+ years of QA experience in pharmaceutical manufacturing or biotech.
- Strong knowledge of GMP, FDA regulations, and ICH guidelines.
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