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Quality Assurance Associate
Job in
Indianapolis, Hamilton County, Indiana, 46262, USA
Listed on 2026-02-22
Listing for:
Harba Solutions Limited
Full Time
position Listed on 2026-02-22
Job specializations:
-
Quality Assurance - QA/QC
Data Analyst -
Healthcare
Data Scientist
Job Description & How to Apply Below
Job Responsibilities
- Review batch records, logbooks, and supporting documentation for accuracy and completeness
- Ensure documentation complies with cGMP requirements and internal SOPs
- Initiate and support deviations, investigations, and CAPAs
- Assist with change controls and impact assessments
- Perform line clearances and in-process quality checks
- Support internal audits and regulatory inspections
- Maintain controlled documentation and support document revisions
- Track and trend quality metrics as assigned
- Collaborate with Manufacturing and QC to resolve quality issues in real time
- Bachelor’s degree in Life Sciences, Chemistry, Biology, Engineering, or related field (or equivalent experience)
- 0–3 years of experience in pharmaceutical, biotech, or medical device manufacturing
- Knowledge of cGMP regulations and FDA guidelines
- Strong attention to detail and documentation skills
- Ability to work cross-functionally in a fast-paced environment
Position Requirements
10+ Years
work experience
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