Quality Control experience in GLP / GCLP laboratory environments
Strong knowledge of regulatory compliance and documentation standards (ALCOA+, 21 CFR Part 11, GxP)
Experience reviewing technical data (ddPCR, RT-ddPCR, ligand binding assays)
Must-Have Skills :
35 years of QC experience in pharmaceutical, biotech, or research laboratory settings
Bachelors degree in a relevant scientific field with 35 years of experience, or Masters with 12 years, or equivalent 79 years of relevant experience
Solid understanding of GLP, GCLP, GCP, CLIA, and related compliance requirements
Experience with data review, documentation, and internal audits under ALCOA+ principles
Strong collaboration and cross-functional communication skills
Ability to write, review, and maintain SOPs and controlled documents
Experience with LIMS systems (LabVantage preferred)
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Healthcare Analyst • Durham, NC, US
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