Related skills
netsuite ngs iso 13485 qpcr pcr📋 Description
- Assist with equipment qualification (IQ/OQ/PQ), PM, and troubleshooting.
- Perform daily maintenance and records per ISO13485.
- Plan and execute validation activities; support stability testing.
- Inventory, material control, and production planning; manage raw materials.
- Reagent product assembly: formulation, filling, labeling, packaging.
- Quality testing: in-process QC and data analysis.
🎯 Requirements
- Bachelor's in biology/molecular biology/genetics or related; or associate degree + 2 yrs exp.
- 1+ years of general laboratory experience.
- 0-2 yrs in medical device manufacturing; 21 CFR 820, ISO 13485, cGMP preferred.
- Strong molecular biology skills: DNA/RNA purification; PCR; qPCR; ddPCR.
- NGS experience: library prep; run instruments; data processing; automation (Hamilton/Bravo) a plus.
- MS Office proficiency; Netsuite ERP experience a plus.
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