The Senior QA/QC Specialist develops, establishes and maintains methodologies, systems and practices which meet the applicable regulatory requirements for Drugs and Biologics and 3DBio procedures as related to Quality Assurance and Quality Control. Serves as a Quality representative to improve awareness of the regulatory and 3DBio requirements to the different functional areas. Communicates quality initiatives in support of departmental, functional quality goals and priorities. Provides Quality support to the product development, manufacturing as related to test and process method development and validation as well as related equipment qualification.
This position will report to the Director of Quality and will will work closely with key stakeholders including Development, Manufacturing, Regulatory and external manufacturers.
Responsibilities to include: