Establish and coordinate the projects Quality Assurance program, process and procedures according to project requirements and industry best practices including ownership of the program Quality Assurance Surveillance Plan (QASP).
Responsible for verifying that each contract products follows a defined process which is in conformance with contractual requirements. Formulate and implement a continuous quality improvement program across the contract that supports process.
Managing Assessment and Authorization, Sustainment, and Continuous monitoring activities across the enterprise, collecting and maintaining accurate status and metrics for all systems, developing and executing plans to remedy problem areas, etc.
Provide strategic plan and expertise for the development and implementation of the Microbial Control Strategy. Develop, document and manage microbial control strategy for Cell Therapy and Bioscience production processes from incoming raw materials through final product release. May manage a staff of 1 -2 specialists or provide guidance , oversight and support for Operations and QA specialists.
Manages and/or performs ehs activities, training and reporting in compliance with epa, osha, and other relevant standards. Coordinates hazardous waster disposals and reporting and other related actions.
Establish and maintain standard processes, supported by a consistent infrastructure to support business customers.Partner with Business Groups and programs to establish and maintain corporate assessments and certifications.
Establish credibility with the teams across the globe by improving collaboration through better organization, communication, understanding of concepts and technologies, respect for all teammates, and an internal drive to achieve.
Plans, develops and implements quality monitoring processes for phone, chat and e-mail responses, monitoring at least one type of interaction for each Knowledge Advisor each month, in most circumstances .