QC Lab Analyst (GMP) – ELISA, HPLC & Validation

AbbVie Inc.; Kansas City (MO); On-site; USD 65,000 - 95,000; Full time

Job summary

AbbVie in the United States seeks a QC Bioassay Specialist to support timely, compliant drug product testing and investigations in a GMP environment. You will perform release and stability analyses, document results, and maintain laboratory data integrity.

The role involves contributing to reagent qualifications, equipment maintenance, root cause investigations, and interpreting results per established standards, with opportunities to develop methods and support critical projects.

Qualifications

• Bachelor of Science in a biological field preferred.
• GxP experience preferred but not required.
• Solid understanding of ELISA-based methods.
• Knowledge of HPLC and UV techniques preferred.
• Experience with method development and validation is a plus.
• Lab experience with mammalian cell culture is advantageous.

Responsibilities

• Perform QC release analysis of commercial finished product per schedule and regulations.
• Perform QC stability analysis per schedule and regulatory requirements.
• Document all laboratory testing activities, results and raw data contemporaneously.
• Adhere to safety, housekeeping and quality standards; notify management of discrepancies.
• Support routine lab duties such as reagent qualifications, inventory, and equipment maintenance.
• Assist with Root Cause Analysis investigations as required.
• Develop proficiency in QC Bioassay IT systems.
• Review and interpret test results according to established standards.

Skills

Data Integrity

Communication

Time management

Teamwork

Problem solving

Technical writing

Education

Bachelor of Science

Tools

HPLC

UV

ELISA

Job description

AbbVie in the United States seeks a QC Bioassay Specialist to support timely, compliant drug product testing and investigations in a GMP environment. You will perform release and stability analyses, document results, and maintain laboratory data integrity.

The role involves contributing to reagent qualifications, equipment maintenance, root cause investigations, and interpreting results per established standards, with opportunities to develop methods and support critical projects.