Quality Control Analyst I
800 Saginaw Drive Redwood City, CA 94063
What You’ ll Do
- The Quality Control Analyst is responsible for release testing in support of nonclinical and clinical viral vector products in compliance with GxP requirements.
- Understands and follows standard operating procedures (SOPs).
- Performs release, stability, and in-process testing of materials, samples, and final products; works with mammalian samples and cell cultures.
- Performs analysis and interpretation of test results, identifies deviations, and makes appropriate recommendations.
- Participates in method and equipment qualification/validation studies; generates protocols, executes and coordinates experiments, and drafts reports.
- May assist in assay development and nonclinical sample testing to support IND-path studies.
- Other responsibilities may be assigned as needed
- Relevant scientific degree with minimum 1-3 years of experience in a bio-pharma analytical laboratory.
- Experience in quality control desired. A strong background in molecular biology is desired. Experience with viral vector (adeno-associated virus) product is a plus.
- Knowledge of cGMPs and regulatory requirements pertaining to biotechnology and pharmaceutical industries desired. Must have laboratory experience with a variety of analytical techniques including, but not limited to, quantitative and/or digital PCR, ELISA, and cell-based methods.
- Knowledge of statistical methods applicable to the analysis of experimental data.
- Proficient in general and non-routine laboratory skills.
- Excellent interpersonal, communication and organizational skills.
- Flexibility in problem solving to meet business objectives. Good oral and written communication skills. MS Office skills; equipment related software such as Soft Max Pro desired.