The Quality Associate supports the Quality Function that they are responsible for within Operations. As a member of the Quality function, provides real-time shop floor oversight to the assigned operations. Partners with Site colleagues to create an environment of the highest performance standards for the operations. Drives continuous improvement in the Operations on site.
Responsibilities
- Responsible for various aspects of quality assurance and quality control related to their functional area.
- Ensures that product within the plant is consistently manufactured in conformance with AbbVie Quality System requirements and all applicable regulatory requirements.
- Partners with Manufacturing SMEs and Shift Supervisors to drive performance of the shift team.
- Completes real-time review of Batch Record documentation and Manufacturing logs.
- Actively supports Quality investigations.
- Completing training activities as required and actively coaching and mentoring colleagues who work in Cleanrooms.
- Participates in routine leadership GEMBAs of Manufacturing and Laboratory areas.
- Provides key input to the development and maintenance of the Site Contamination Control Strategy.
- Provides key input to the assessment of EM data and trends.
- Serve as an expert and as a consultant in clean room good practices and behaviors.