Technical Writer Job

HIRINGGG !!!!!!!!!!!! Senior Lab Instruments Software Validation Analyst / Technical Writer - Highland Heights, KY (Onsite) Visa: H1B accepted Experience: 12+ years (10+ in lab/software validation; 5+ hands-on in analytical instruments & equipment qualification) Key Skills: Validation (DQ, IQ, OQ, PQ) & documentation (URS, FRS, Risk, Trace Matrix, VSR) FDA 21 CFR Part 11, EU Annex 11, GAMP 5, cGMP compliance Analytical instruments: spectroscopy, chromatography, PCR, sequencing Risk assessment, CAPA, SOPs, and lifecycle management Strong leadership, technical writing, and cross-functional collaboration

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