Purpose :
Describes the primary goals,objective or function or outputs of this position.
The Quality Associate supports the Quality Function that they are responsible for within Operations. This could include: Incoming Quality Assurance of drugs and packaging materials, Manufacturing Quality Assurance, Validation, Quality Engineering, Training and Regulatory Compliance. Expectations that the Quality Associate will maintain high quality levels on all aspects of their job while achieving high levels of efficiency.
Responsibilities :
List up to 10 main responsibilities for the job. Include information about the accountability and scope.
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 :
List required and preferred qualifications up to 10). Include education, skills and experience.
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