QC Data Reviewer: GMP & Data Integrity

ABBVIE; Worcester (MA); On-site; USD 59,000 - 99,000; Full time

Benefits offered by this job

Paid time off

Medical/dental/vision insurance

401(k) plan

Job summary

AbbVie in Worcester, MA seeks an Associate Data Reviewer, QC to support the Quality Function within Operations. You will perform routine and STAT data reviews, assist in QA/QC of drugs and packaging materials, and ensure conformance with cGMP and regulatory requirements.

Responsibilities include completing assays reviews, data mining, archiving, and coordinating with management on quality initiatives. A bachelor’s degree or equivalent experience is required.

Qualifications

• Bachelor’s degree or 2+ years in pharma manufacturing, QA, QC, or R&D.
• Experience with electronic document management and LIMS.
• Familiarity with Quality Systems, cGMP, and applicable regulatory requirements.
• Strong verbal and written communication skills.

Responsibilities

• Performs routine and STAT review of lab data, on- and off-floor, for low-complexity methods.
• Completes review of assays, data mining projects, and data archiving.
• Ensures quality assurance and control within the functional area.
• Ensures product manufacturing conforms to AbbVie Quality System and regulatory requirements.
• Supports troubleshooting and resolution of quality compliance issues.
• Communicates with management on Quality Management Review and initiatives.
• Makes quality decisions to ensure compliance with quality systems and cGMP.

Skills

Strong verbal and written comms

Education

Bachelor’s degree or equivalent experience

Tools

Electronic document management systems

Laboratory information management systems (LIMS)

Quality Management Systems (QMS)

Job description

AbbVie in Worcester, MA seeks an Associate Data Reviewer, QC to support the Quality Function within Operations. You will perform routine and STAT data reviews, assist in QA/QC of drugs and packaging materials, and ensure conformance with cGMP and regulatory requirements.

Responsibilities include completing assays reviews, data mining, archiving, and coordinating with management on quality initiatives. A bachelor’s degree or equivalent experience is required.