QC Analyst II
Netpace Inc · Oceanside, CA · 10 mo ago
On-siteQuality AssuranceContract
The Opportunity
- Conduct quality control testing on products and materials
- Analyze test results and report deviations
- Ensure compliance with GMP and regulatory standards
- Document quality control procedures and findings
- Afford assistance in troubleshooting and root cause analysis
Who You Are
- 5-10 years of experience, specifically BioAssay or Cell Culture required
- Strong problem-solving skills
- Excellent communication abilities
- Knowledge of industry best practices
Preferred Experience with laboratory GMP testing required
Additional Notes
Key Responsibilities
- Maintain mammalian cell lines, including transferring between incubators
- Run plate-based, cell-based assays, and multi-channel assays
- Conduct ELISA and BioAssay testing, including different cell cultures
- Initiate deviations and perform troubleshooting
- Ensure adherence to GMP and QC standards
- Work with Veeva document system and other QA record platforms
- Knowledge of drug and antibiotic testing at 80°C
Required Skills & Experience
- Minimum 5-10 years of experience in GMP environments (3-4 years may be considered if in-depth BioAssay knowledge)
- Bachelor's or Master's degree preferred; high school minimum acceptable
- Experience with cell culture, maintaining cell lines, ELISA assays, BioAssay, cell-based assays, and different cell cultures
- Familiarity with QMS, Nextlab tools, and electronic documentation systems
- Experience in assay panel testing and binding/curve analysis
Top 3 Must-Have Skills
- Cell culture - maintain cell lines
- ELISA assay
- BioAssay