Quality Control Analyst III
1035 O'Brien Drive Menlo Park, CA 94025
Menlo Park, CA
Analyst III, Quality Control
Our client' s Quality Control team is looking to bring on-board an Analyst III. This individual will be a crucial member of the Quality Control team, contributing to the development and performance Quality Control (QC) methods, systems, policies, processes, procedures and controls as they relate to the analytical testing of clinical materials.
Core Duties and Responsibilities:
- The Quality Control Analyst is responsible for release testing in support of nonclinical and clinical viral vector products in compliance with GxP requirements.
- Develops, optimizes, modifies, 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 lead QC projects and investigations as necessary.
- May assist in assay development and nonclinical sample testing to support IND-path studies.
- Provides guidance to junior staff and applies technical knowledge daily.
Position Requirements and Experience:
- Relevant scientific degree with minimum 4-6 years related experience in a bio-pharma analytical laboratory.
- Experience in quality control required. A strong background in molecular biology is desired.
- Experience transferring assays from Assay Development to Quality Control is desired.
- Experience in assay qualification and validation strongly desired. Experience with viral vector (adeno-associated virus) product is a plus.
- Knowledge of cGMPs and regulatory requirements pertaining to biotechnology and pharmaceutical industries required. 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.
- Experience working with contract testing labs.
- Excellent interpersonal, communication and organizational skills.
- Ability to make sound decisions about team activity scheduling, allocation of resources, and priorities.
- 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.