Quality Assurance Operations Specialist

Our client, a world leader in biotechnology and life sciences, is looking for a <\/span>"Quality Assurance Operations Specialist” based out of Philadelphia, PA.<\/span><\/b><\/span>
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Job Duration: Long Term Contract (Possibility Of Extension)<\/span><\/span><\/b>
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Pay Rate : $42/hr on W2<\/span><\/span><\/b>
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Company Benefits:<\/span><\/span><\/b> Medical, Dental, Vision, Paid Sick leave, 401K<\/span><\/span>
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Duration: Long term contract (Possibility of further extension)<\/span><\/span><\/b>
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The Quality Assurance Operations Specialist provides quality oversight and technical support for manufacturing operations in a regulated environment. This role ensures compliance with cGMP requirements through review of batch records, deviations, investigations, change controls, CAPAs, and material release activities, supporting both clinical and commercial manufacturing.<\/span><\/span>
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Key Responsibilities<\/span><\/span><\/u><\/b>
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• Provide QA oversight during manufacturing activities<\/span><\/span>
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• Review executed batch records, deviations, and product disposition decisions<\/span><\/span>
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• Open, manage, and close deviations, investigations, change controls, and CAPAs<\/span><\/span>
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• Review QC testing records and OOS investigations<\/span><\/span>
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• Review, write, revise, and approve SOPs and technical documentation<\/span><\/span>
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• Perform material inspection and release; review vendor CoCs/CoAs<\/span><\/span>
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• Compile and analyze quality metrics and trending data<\/span><\/span>
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• Support Quality Management System (QMS) integration and improvement projects<\/span><\/span>
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• Support Quality Risk Management and Change Control governance<\/span><\/span>
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• Prepare CoCs and CoAs for clinical and commercial materials<\/span><\/span>
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  Qualifications<\/span><\/span><\/u><\/b>
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  • Bachelor’s degree in a scientific discipline<\/span><\/span>
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  • 3–5 years of experience in a regulated manufacturing environment<\/span><\/span>
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  • Working knowledge of Quality Systems (Deviations, CAPA, Change Control)<\/span><\/span>
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  • Strong technical writing and communication skills<\/span><\/span>
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  • Knowledge of cGMP regulations and guidelines<\/span><\/span>
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    If interested, please send us your updated resume at<\/span><\/span>
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    hr@dawarconsulting.com

    akansha@dawarconsulting.com

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