Quality Control Associate

The Quality Control Associate will perform testing of raw materials, in -process materials, and finished goods in a regulated cGMP/ISO 13485 environment. This role is responsible for maintaining accurate documentation, supporting quality investigations, and ensuring compliance with regulatory standards. The ideal candidate will work cross -functionally to support QC operations, reagent manufacturing, and continuous improvement initiatives.
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Key Responsibilities:<\/b>
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• Perform inspection and testing of raw materials, in -process, and finished goods.
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• Document results, complete batch records, and generate QC reports.
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• Maintain Device History Records (DHR) and ensure compliance with cGMP and regulatory requirements.
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• Conduct data analysis and support process monitoring and trending.
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• Investigate Out of Specification (OOS) results and support CAPA activities.
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• Perform routine maintenance and calibration checks of lab equipment.
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• Support environmental monitoring and maintain QC lab readiness.
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• Assist in reagent formulation and manufacturing activities.
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• Manage lab inventory, supplies, and vendor coordination.
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• Participate in validations, method development, and process transfers.
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  Quality & Compliance:<\/b>
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  • Ensure adherence to FDA, ISO, GMP, and OSHA standards.
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  • Maintain accurate documentation for material handling, storage, and release.
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  • Support audits, safety reporting, and quality system compliance.
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    Qualifications:<\/b>
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    • High School Diploma (Associate’s or Bachelor’s in Life Sciences preferred).
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    • 0–7 years of experience in a laboratory or regulated industry.
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    • Experience in cGMP/GLP/ISO environments preferred.
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      Skills & Requirements:<\/b>
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      • Strong analytical, troubleshooting, and data analysis skills.
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      • Hands -on lab experience (pipetting, titration, spectroscopy, etc.).
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      • Excellent documentation and organizational skills.
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      • Ability to work in a fast -paced, team -oriented environment.
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      • Familiarity with Lean/6S practices is a plus.
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        Company Benefits:<\/span><\/span><\/span><\/b> Medical, Dental, Vision, Paid Sick leave, 401K
        
        If interested, please share your update resume at <\/span><\/span><\/span>

        hr@dawarconsulting.com

        kavitha@dawarconsulting.com