Qureos Mentor

Harba Solutions Inc.

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 Key Responsibilities
 
 
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 Review and approve quality documentation, including batch records, deviations, change controls, and validation-related documents
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 Partner with Manufacturing and Operations to support and/or lead deviation investigations, including root cause analysis and corrective actions
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 Maintain a strong QA presence on the manufacturing floor to ensure compliance and provide real-time support
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 Balance production timelines with quality requirements to support efficient operations
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 Perform material review and release activities for raw materials, components, and consumables
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 Support batch record review, product disposition, and overall release processes
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 Mentor and provide guidance to QA team members on shift
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 Make real-time quality decisions regarding deviations, product impact, and escalation needs
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 Contribute to deviation investigations, CAPA development, and risk assessments
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 Ensure adherence to SOPs, regulatory requirements, and site quality standards
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 Utilize electronic and paper-based systems (QMS, LIMS, etc.) to maintain data integrity
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 Analyze quality trends and identify sources of variability using data and statistical tools
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 Manage multiple priorities in a fast-paced GMP environment
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 Qualifications
 
 
 <ul>
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 Bachelor&rsquo;s degree in a scientific discipline (or equivalent experience)
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 8+ years of experience in a GMP-regulated manufacturing environment
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 4+ years of direct QA oversight supporting manufacturing operations
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 Experience with quality systems, including deviations, CAPA, and change control
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 Strong understanding of GMP regulations and product disposition processes
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 Excellent written and verbal communication skills
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 Experience with data analysis tools and manufacturing systems is preferred
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 </ul>
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Senior Quality Assurance Specialist

Join Harba Solutions Inc. and explore 1   exciting career opportunities. They're hiring for various roles with options for remote or on-site work. Apply today and become part of their innovative team.

Harba Solutions Inc.

About Company

Senior Quality Assurance Specialist