What are the responsibilities and job description for the Quality Control Analyst II position at Harba Solutions Inc.?
Job Responsibilities
- Conduct routine quality control testing, including ddPCR/dPCR and qPCR methods for in-process, release, and stability assessments.
- Maintain laboratory operations, including equipment and workspace upkeep, inventory management, and documentation control.
- Assist with the development, transfer, and validation of qPCR and dPCR-based assays for lot release and stability testing.
- Author and update standard operating procedures (SOPs), forms, and other controlled documentation.
- Perform peer reviews of internally and externally generated data to ensure accuracy and compliance.
- Support investigations related to QC deviations, method performance trending, and root cause analysis.
- Contribute to laboratory inspection readiness and participate in troubleshooting and process improvement initiatives.
- Perform additional duties as needed.
Qualifications
- Bachelor's or Master's degree in Molecular Biology, Cell Biology, Biochemistry, or a related field.
- Knowledge of viral vectors and biologics is preferred.
- Minimum of 2 years of industry experience in a quality control setting.
- Familiarity with GMP regulations and quality standards.
- Hands-on experience with dPCR, ddPCR, and qPCR test execution.
- Experience with statistical analysis of analytical data and stability studies.
Salary : $33 - $48
