Associate Data Reviewer, QC

The Associate Data Reviewer, QC supports the Quality Function that they are responsible for within Operations. This could include: GMP Data review, 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
Performs Routine and STAT Review of Lab test data including On-the-Floor Review, and Off-the-Floor Review for low complexity test methods.
Complete review of assays, data mining projects, and archiving of data
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.
Bachelor’s degree, or at least 2 years of combined experience in manufacturing, QA, QC, or R&D within the pharmaceutical or biologics industry.
Working knowledge of electronic document management and laboratory information management systems.
Familiarity with Quality Systems, cGMP, and other applicable regulatory requirements.
Strong verbal and written communication skills.
Shift: Sunday- Wednesday, 6am-4pm

Employment type
Full-time

Work arrangement
No