Overview
Quality Assurance Specialist Jobs in Raleigh-Durham-Chapel Hill Area at Elevait Solutions
Title: Quality Assurance Specialist
Company: Elevait Solutions
Location: Raleigh-Durham-Chapel Hill Area
ob Title: Quality Assurance Specialist – GLP/GCLP
Industry: Biotech / Clinical & Preclinical Research
Location (City, State): Research Triangle Park, NC
Worksite: Onsite
Top 3 Skills
- :GLP/GCLP Auditin
- gImmunogenicity Assays (NAb/TAb & ddPCR
- )Regulatory Compliance (21 CFR Part 11
)What You'll D
- oAudit studies, processes, reports, and data for compliance with GLP, GCLP, and applicable regulation
- sPerform in-process inspections of nonclinical study phases and assay method
- sFollow up on audit findings and drive resolution with the appropriate team
- sAct as a go-to compliance resource for lab and scientific staf
- fSupport oversight of clinical and preclinical sample analysis activitie
- sEnsure adherence to protocols, SOPs, and controlled documents across laboratory operation
sWhat We Need From Yo
- uBachelor's degree in a scientific or healthcare-related fiel
- d3+ years of relevant industry experience in QA or a laboratory settin
- gHands-on audit experience — this is a mus
- tStrong working knowledge of GLP, GCLP, and 21 CFR Part 1
- 1Robust familiarity with immunogenicity assays — NAb, TAb, and ddPCR specificall
- yAbility to work cross-functionally in a matrixed environment without losing momentu
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