Quality Control Lead
800 Saginaw Drive Redwood City, CA 94063
What You’ ll Do
- Review executed QC test records for product release, including the investigation and resolution of deviations, OOS and OOT observations.
- Perform routine QC testing as needed
- Write, organize and review QC analytical result tables, protocols and reports.
- Work in conjunction with Assay Development department to qualify, validate and transfer QC analytical methods as applicable
- Manage and build sample control processes for GMP release, stability, and/or additional test samples
- Lead routine cell culture, reagent preparation, and other laboratory testing support activities
- Lead and/or review equipment/instrument IOQ/PQ (vendor)
- Implement and manage equipment/instrument maintenance/calibration
- Work with QC management to identify and mitigate risks to meeting QC milestones and goals.
- Coordinate with the Quality Assurance department for required review and approval of documents
- Oversee and provide direction to the direct reports under the guidance of the QC Management
- 5 to 7 years in a GMP environment (pharmaceutical or biotechnology industry)
- Solid knowledge and understanding of US and international regulations and guidance applicable to Quality Control and method validation
- Experience in quality control required. A strong background in molecular biology is desired.
- Experience transferring assays from Assay Development to Quality Control is required.
- Experience in assay qualification and validation strongly desired. Experience with viral vector (adeno-associated virus) product is a plus.
- Experience with adherent and suspension cell culture is required. Experience with HEK293 and Sf9 cells 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 PCR, ELISA, and cell-based methods.
- Knowledge of statistical methods applicable to the analysis of data.
- Proficient in general and non-routine laboratory skills.
- Experience working with contract testing labs.
- Excellent interpersonal, communication and organizational skills.
- Flexibility in problem solving, providing direction and work hours to meet business objectives. Good oral and written communication skills. MS Office skills; equipment related software such as Soft Max Pro desired.