Reagent Bulk Technician
Title: Reagent Bulk & Fill Technician IV (Variable Shift)
Location: San Diego, CA 92127
Duration: 7 months (extension likely)
40 hrs/week | Variable shifts (1st, 2nd, 3rd + weekends as needed)
Morning (6am to 2.30 pm) OR Afternoon (2pm to 10.30pm)
Summary:
Senior manufacturing technician responsible for bulk reagent formulation and automated filling operations supporting clinical/commercial diagnostic kits, including aliquoting, packaging, in‑process inspection, sampling for QC/bioburden, and strict cGMP documentation.
Key Requirements:
- Manufacture bulk reagents: raw material staging, weighing/measuring, formulation, bulking/filling/aliquoting/packaging
- Operate/lead setup, changeover, and troubleshooting of automated fill equipment (independently run majority of machines)
- Strong documentation: DHR completion/review, logbooks, training records; update SOP/DMR documents
- Systems: perform transactions in SAP/ERP (materials, consumption, labor, sampling, labeling)
- Quality: support QN investigations, CAPA feedback, audit readiness; demonstrate processes in FDA/ISO/internal audits
- Material handling for temperature‑sensitive semi-finished goods (blood screening kits), visual inspection and sampling
- Lead/support cycle counts, KPI reporting; mentor/train junior techs; maintain housekeeping and safety compliance
- Flexibility: variable shifts + weekends; adjust PTO around plant shutdowns (Aug 2026 and late Dec 2026)
- Education: HS/GED required; Associate degree preferred
- Training/Compliance: GMP/GDP/ISO knowledge; Blood Borne Pathogen training noted