QA Associate

Role Summary

The Quality Associate supports the Quality Function within Operations. This could include: Incoming Quality Assurance of drugs and packaging materials, Manufacturing Quality Assurance, Validation, Quality Engineering, Training and Regulatory Compliance. Expectations are to maintain high quality levels on all aspects of the job while achieving high levels of efficiency.

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.
• Support troubleshooting and resolution of quality compliance issues.
• Communicates with Management for Quality Management Review, Quality Initiatives, etc.
• Incumbent is responsible for quality decisions related to their functional area to ensure compliance with AbbVie Quality Systems and cGMPs.

Qualifications

• Bachelor’s Degree OR 2+ years of combined experience in Manufacturing, QA, QC, R&D in pharmaceutical or biologics industry.
• Must be familiar with use of electronic document management and laboratory information management.
• Must also be familiar with Quality Systems as well as cGMP and other regulatory requirements.
• Strong communication skills, both oral and written.