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Job: Quality Assurance Specialist II, CoImmune Inc., Durham, NC
Quality Assurance Specialist II
Durham, NC 27704 United States
SCOPE: This individual will utilize developed, internal quality systems, procedures, and practices to support manufacturing of a cellular based product in a cGMP compliant environment. This position will also assist in the development of new systems and maintenance of existing systems.
• Provide QA review of GMP documentation, including Item Specifications, SOPs, production records and test methods along
with validation protocols and reports
• Author or revise SOPs and item specifications
• Initiate and approve Quality System documents including deviations, CAPAs, Change Requests and non-conforming reports
• Review executed batch records and participate in the disposition of Clinical Trials Materials (CTMs) including review of all
associated documentation and transfer of materials from manufacturing to QA
• Assist with issuance, review and archiving of controlled documents as needed
• Provide QA review and release of incoming raw materials (including blood products) and serve as a resource in resolving
• Provide QA review and oversight for product shipments
• Work on problems of moderate scope in which analysis of the situation or data requires a
review of identifiable factors, such as those exhibited in Deviation Reports
• Review QC results as needed
• Assist with internal and external audits, as required
• Participate in the initiation, receipt, and review of Vendor Surveys
• Other duties as required
• Prefer Bachelors or Masters degree in a scientific discipline or equivalent
• A minimum of three years industrial cGMP experience in an FDA regulated Biopharmaceutical
environment with 2+ years QA experience
• 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 (< 10%)
Work is a mixture of sedentary and physical. Standing, with some occasional physical demands such as with pushing, pulling and lifting is required. Some work will require working with ultra-cold materials for a short amount of time while wearing personal protective equipment.
The requirements listed in this job description are representative of the management’s assignment of essential function, with knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. Nothing in this herein restricts management’s right to assign or reassign duties and responsibilities to this job at any time. Furthermore, the job description doesn’t constitute a contract of employment and CoImmune Inc. may exercise its employment-at-will at any time.
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