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Quality Assurance Specialist

Company: The Veritas Healthcare Solutions LLC.
Location: Princeton
Posted on: November 19, 2021

Job Description:

Serve as reviewer and approver for protocols and reports relating to manufacturing process, validation, and other studies. ? Serve as expert reviewer for studies, reports, project plans, regulatory submissions, and other documents relating to process understanding, characterization, and validation. ? Participate in batch release and all quality systems associated with batch release: o Review of manufacturing and testing records to ensure compliance to site procedures, regulatory requirements, and product license requirements. o Review deviation investigations, including root cause analysis. o Support the development and execution of CAPA plans to address identified deviation root causes or compliance/quality gaps. o Coordinate and support the development and execution of change control plans to ensure compliant implementation of product and/or process changes. ? Critically review various types of documentation to ensure completeness, accuracy, and compliance, including: SOP revisions, protocols, data sets, material specifications, work orders, calibration records, and validation reports. ? Represent the department in interactions with internal functional units and external clients, or regulatory officials during site audits as needed. ? Serve as point person for clients requiring assistance in preparation and/or review of regulatory submissions, Annual Product Reviews, client change notifications, and Quality Agreements. ? Technical lead / support for site inspections from clients and regulatory agencies including escorting inspectors, speaking as Quality Assurance subject matter expert, and preparing documentation for auditor review. ? Respond to internal and external audit findings. ? Perform gap assessments of site systems and processes against corporate standards, and applicable regulatory requirements Job Types: Full-time, Contract Pay: $45.00 - $48.00 per hour Benefits: Health insurance Schedule: 8 hour shift Education: High school or equivalent (Preferred) Experience: Manufacturing: 1 year (Preferred) Shift availability: Day Shift (Preferred) Work Location: Multiple Locations

Keywords: The Veritas Healthcare Solutions LLC., Trenton , Quality Assurance Specialist, Other , Princeton, New Jersey

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