GMP Data Reviewer, Quality Assurance QC

AbbVie Inc.; Worcester (MA); On-site; USD 70,000 - 90,000; Full time

Job summary

AbbVie is seeking an Associate Data Reviewer in QC to support the Quality Function within Operations. The role involves GMP data review, QA/QC activities, and ensuring products are manufactured to AbbVie Quality System and regulatory requirements.

The position requires a Bachelor’s degree or 2+ years in pharma/biologics, experience with electronic document management and LIMS, and strong communication skills. Shift: Sun-Wed, 6am-4pm.

Qualifications

• 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.

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.

Skills

Strong verbal and written comms

Education

Bachelor’s degree or 2+ years pharma/biologics experience

Tools

EDMS

LIMS

Job description

AbbVie is seeking an Associate Data Reviewer in QC to support the Quality Function within Operations. The role involves GMP data review, QA/QC activities, and ensuring products are manufactured to AbbVie Quality System and regulatory requirements.

The position requires a Bachelor’s degree or 2+ years in pharma/biologics, experience with electronic document management and LIMS, and strong communication skills. Shift: Sun-Wed, 6am-4pm.