BioPhase Solutions specializes in recruiting top talented professionals for San Diego's Scientific community. We are currently looking for a QC Manager to work for a leading San Diego County biotechnology company.
Ensure that the health of the product is maintained via metrics and corrective actions in the receiving in process, final inspection, and customer feedback loops.
Responsible for the inspection & testing of raw materials, in process sampling, and product release of finished goods. Interface directly with manufacturing to ensure that products produced comply with all in process quality monitoring metrics and final product quality attributes. Identify product quality improvements that may achieve better performing raw materials. Provide technical guidance in DOE to improve product quality. Create and manage metrics that manage the overall quality health of the product. Ability to identify and report non-conformances thru the Quality System. Maintain a product stability monitoring program. Investigate customer feedback. Ensure the QC spreadsheets are kept up to date and are accurate. Maintain the stability monitoring program. Provide daily management of the QC group. Provide mentorship/leadership. Create and manage quality inspection and test SOPs. Manage the measurement and test equipment to ensure compliance (including IQ/OQ/PQ). Utilize labor in a productive and effective manner. Ability to create meaningful metrics relating to product performance Manage key metrics that signal immediate action within Manufacturing that maintain or improve product quality. Determine metrics that drive product performance improvements. Maintain the product stability monitoring program and identify any performance issues Ensure that lateral flow devices produced perform acceptably in a reflectance reader. Maintain and/or improve product quality by supporting the quality requirements of new materials (e.g. foil pouch material, adulterant pads…).
Root cause analysis, investigative skills, and ability to implement & monitor corrective actions. Statistical process control experience utilizing 6 sigma or similar approach. Technical understanding of reflectance reader systems and lateral flow device performance. Mechanical measurements. Immunoassay exposure
Technical or scientific degree-required Statistical analysis background-required Prior QC management experience- desired Research Associate experience- desired Lean/6 sigma experience- desired
Contact if interested!
Monster - 14 months ago