QC Analyst II

Quality Control Testing Specialist

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

Assist 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:

1. Cell culture – maintain cell lines
2. ELISA assay
3. BioAssay