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Job: Quality Assurance Specialist, CoImmune Inc., Durham, NC

General Information

Job title:
Quality Assurance Specialist
Job location:
Durham, NC  27704 United States
Requisition code:
Date posted:
Job category:
Quality Assurance
Employment type:
Full time

Job Description

This individual will utilize developed, internal quality systems, procedures, and practices to cGMP manufacturing of a cellular based product under a cGMP compliant environment. Will assist in the development of new and maintaining existing systems.

• Assist with QA review of GMP documentation, including Item Specifications, SOPs, production records, validation protocols
and reports.
• Initiate and approve Deviations, CAPAs, Change Request and non-conforming reports.
• Review executed batch records and participate in the disposition of Clinical Trials Materials (CTMs) including review of all
associated documentation.
• Assist in Material Review Board (MRB) meetings and Management Reviews preparation.
• Provide QA review and release of incoming raw materials and serve as a resource in resolving discrepancies.
• Provide QA review and oversight for product shipments.
• Review and organize the archiving of executed batch records.
• Review QC results.
• Conduct internal and external audits as required.
• Organize initiation, receipt, and review of Vendor Surveys.
• Other duties as required

Job Requirements

• Prefer Bachelor's or Master's degree in a scientific discipline or equivalent
• A minimum of five years industrial cGMP experience in an FDA regulated Biopharmaceutical environment with 3+ years QA
• Strong writing and verbal communication skills
• Strong computer skills (Word, Excel, PowerPoint, etc.)
• Must have experience auditing to cGMP standards and writing and maintaining controlled documents
• Strong interpersonal communication skills
• Demonstrated initiative and attention to detail
• Demonstrated ability to multitask and meet deadlines
• Ability and willingness to be regularly, predictably and reliably at work
• Willingness to travel for external audits

Work is primarily sedentary in nature.
(Job number: 3839037)
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