This role involves leading the analysis of biologics and vaccines in a state-of-the-art Quality Operations laboratory while ensuring compliance with corporate and regulatory requirements
Job Summary
This role involves leading the analysis of biologics and vaccines in a state-of-the-art Quality Operations laboratory while ensuring compliance with corporate and regulatory requirements.
The successful candidate will act as a subject matter expert for analytical methods, driving continuous improvements and resolving system failures using tools like FMEA and Fishbone diagrams.
As a lead in the QC team, you will mentor junior staff, peer review documentation to ensure data integrity, and lead laboratory aspects of Out of Specification (OOS) investigations.
Matching Summary
This role involves leading the analysis of biologics and vaccines in a state-of-the-art Quality Operations laboratory while ensuring compliance with corporate and regulatory requirements.
Skills & Requirements
Must-have
HPLC system operation and software
cGMP and GLP compliance knowledge
Root cause analysis using FMEA Fishbone
ELISA and Capillary Electrophoresis techniques
OOS investigation leadership
Peer review of testing documentation
Nice-to-have
Mentoring junior team members
Driving continuous improvement initiatives
Leading internal and external audits
Experience with method validation protocols
Strong communication during daily meetings
Key Requirements
Bachelor's Degree in Analytical Chemistry or Biochemistry
2-3 years experience in pharmaceutical laboratory
Good working knowledge of HPLC systems and software