Quality Assurance Associate

About the role

As a member of the Quality function, the Quality Associate provides real-time shop floor oversight to the assigned operations within AbbVie’s Operations. They partner with Site colleagues to create an environment of the highest performance standards for the operations and drive continuous improvement.

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.
• Completes training activities as required and actively coaches and mentors 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 Environmental Monitoring (EM) data and trends.
• Serves as an expert and consultant in cleanroom good practices and behaviors.

Requirements

• Associate Degree in a Science, Quality or Engineering discipline.
• 4+ years of experience in a pharmaceutical and/or medical device regulated environment.
• Knowledge of Regulatory Requirements.
• Excellent communication skills.

Schedule

B2 Shift: 5:45pm–6:00am, Wednesday–Friday and every other Saturday.