Primary Skills: Immunoassay Techniques (advanced), Data Analysis (advanced), Regulatory Compliance (intermediate), FDA/ISO design controls (advanced), Laboratory Skills (advanced)
Contract Type: W2
Duration: 12 Months
Location: Fremont, CA - 94538 (#LI - Onsite)
Pay Range: $35 - $40 per hour on W2
#LP
Job Summary: This hands-on role involves conducting critical analytical performance verification for IVD immunoassay products. You will be responsible for designing and executing experiments to generate data that supports regulatory submissions. The position requires strong analytical abilities, meticulous documentation, and effective collaboration within a dynamic R&D environment.
Key Responsibilities:
- Design and perform analytical performance verification studies.
- Develop and execute experimental protocols.
- Analyze, interpret, and report experimental data.
- Ensure compliance with regulatory standards.
- Troubleshoot experimental issues and propose solutions.
Must-Have Skills:
- Proficiency in immunoassay techniques.
- Strong data analysis and interpretation skills.
- Excellent documentation and communication abilities.
Minimum Requirements: Bachelor’s degree in chemistry, biochemistry, molecular biology, immunology, microbiology, bioengineering or related life sciences discipline
Experience with In Vitro Diagnostic (IVD) product development and regulatory environments is highly preferred.
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