Quality Assurance Associate - Real-Time Cleanrooms

ABBVIE; Waco (TX); On-site; USD 43,000 - 76,000; Full time

Benefits offered by this job

Paid time off

Medical/dental/vision insurance

401(k)

Job summary

AbbVie is seeking a Quality Associate to provide real-time shop floor oversight within Operations. You will work with site colleagues to uphold the highest quality standards, driving continuous improvement on site and ensuring conformance to AbbVie Quality System requirements and all applicable regulatory requirements.

Responsibilities include batch record review, supporting investigations, and coaching colleagues in cleanroom practices, with active participation in leadership GEMBAs and

Qualifications

• 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.

Responsibilities

• Provide real-time quality oversight on the shop floor.
• Ensure products are manufactured in conformance with AbbVie Quality System requirements and regulatory requirements.
• Collaborate with Manufacturing SMEs and Shift Supervisors to drive shift performance.
• Review Batch Records and Manufacturing logs in real time.
• Support quality investigations as needed.
• Complete training and coach colleagues working in Cleanrooms.
• Participate in routine leadership GEMBAs of Manufacturing and Laboratory areas.
• Contribute to the Site Contamination Control Strategy and EM data trend assessments.

Skills

Quality assurance

GxP knowledge

Regulatory awareness

Education

Associate Degree in Science/Quality/Engineering

Job description

AbbVie is seeking a Quality Associate to provide real-time shop floor oversight within Operations. You will work with site colleagues to uphold the highest quality standards, driving continuous improvement on site and ensuring conformance to AbbVie Quality System requirements and all applicable regulatory requirements.

Responsibilities include batch record review, supporting investigations, and coaching colleagues in cleanroom practices, with active participation in leadership GEMBAs and