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Quality Assurance Associate
Job in
Indianapolis, Hamilton County, Indiana, 46262, USA
Listed on 2026-02-21
Listing for:
Harba Solutions Limited
Full Time
position Listed on 2026-02-21
Job specializations:
-
Quality Assurance - QA/QC
Quality Engineering, Quality Control / Manager
Job Description & How to Apply Below
Job Responsibilities
- Provide Quality oversight on the manufacturing floor to ensure processes meet established quality and compliance standards
- Review and approve GMP documentation, including batch records and operational logs
- Partner with Manufacturing and Operations teams to support investigations related to process or equipment deviations
- Support batch record review, material disposition, and product release activities
- Assess deviations to determine scope, impact, and appropriate containment or escalation actions
- Contribute to deviation investigations using root cause analysis and risk-based approaches
- Promote a strong culture of safety, quality, and compliance
- Ensure data integrity through accurate documentation in paper-based and electronic systems
- Analyze trends and process variability to support continuous improvement initiatives
- Manage multiple priorities effectively in a fast-paced manufacturing environment
- Bachelor’s degree required (or equivalent experience); scientific discipline preferred
- 2+ years of experience in a regulated manufacturing environment in Quality and/or Operations
- Working knowledge of GMPs, quality systems, and deviation management
Strong understanding of Good Documentation Practices - Excellent written and verbal communication skills
- Comfortable working with computerized manufacturing or operational systems
2nd or 3rd shift
#J-18808-LjbffrPosition Requirements
10+ Years
work experience
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