Job Description
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Quality Assurance Specialist III
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📍 Raleigh, NC |
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📅 6-Month Contract
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We are looking for a Quality Assurance Specialist III to provide QA oversight and auditing support for clinical and preclinical studies. This role will ensure compliance with GCP, GLP, GCLP, 21 CFR Part 11, and applicable regulatory requirements.
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Key Requirements:
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- Bachelor’s degree in a relevant scientific or healthcare field
- 5+ years of relevant industry experience
- Laboratory and Quality Assurance experience
- Audit experience required
- Strong knowledge of GLP/GCLP and 21 CFR Part 11
- Experience with Immunogenicity (NAb/TAb) and ddPCR assays required
- Strong communication, collaboration, and problem-solving skills
- Proficiency in MS Word, Excel, and PowerPoint
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