QC Analytical Scientist – GMP Lab & Method Validation

SmartRecruiters, Inc.; Westport; On-site; EUR 45,000 - 65,000; Full time

Job summary

AbbVie is seeking a qualified QC Bioassay professional to support timely, compliant testing and investigations in accordance with GMP and regulatory requirements. The role involves releasing finished product QA/QC analyses, method validation support, and data integrity in all lab activities.

The candidate will work within a team, contribute to reagent qualifications, and participate in root cause investigations while maintaining safety, accuracy, and proper documentation.

Qualifications

• Minimum requirement of Bachelor of Science. Qualifications in a biological field are preferable.
• Previous GxP experience is preferable but not required.
• Sound scientific/practical understanding of ELISA based methods.
• Knowledge and practical experience in HPLC and UV techniques is preferable.
• Knowledge of method development and validation preferable.
• Practical experience of mammalian cell culture and basic techniques (Passaging, freeze-down, drug treatments) is an advantage.

Responsibilities

• Perform QC release analysis of commercial finished product as per schedule and in accordance with regulatory requirements.
• Perform QC stability analysis as per schedule and in accordance with regulatory requirements.
• Document all laboratory testing activities, results and raw data contemporaneously, accurately and legibly.
• Adherence to all company standards in the areas of safety, housekeeping and quality, notifying management of any discrepancies.
• Contribute to routine lab duties such as critical reagent qualifications, inventory management and equipment maintenance.
• Support Root Cause Analysis investigations where required.
• Develop proficiency in all laboratory IT systems required by QC Bioassay
• Develop the skills required to review and interpret test results via established standards and requirements.

Skills

Data Integrity

Communication

Organization

Time Management

Teamwork

Problem Solving

Technical Writing

Right First Time

Education

Bachelor of Science

Tools

ELISA

HPLC

UV Techniques

Job description

AbbVie is seeking a qualified QC Bioassay professional to support timely, compliant testing and investigations in accordance with GMP and regulatory requirements. The role involves releasing finished product QA/QC analyses, method validation support, and data integrity in all lab activities.

The candidate will work within a team, contribute to reagent qualifications, and participate in root cause investigations while maintaining safety, accuracy, and proper documentation.