This role involves performing and reviewing routine and non-routine testing to ensure compliance with corporate and regulatory requirements for biologics and vaccines
Job Summary
This role involves performing and reviewing routine and non-routine testing to ensure compliance with corporate and regulatory requirements for biologics and vaccines.
The successful candidate will act as a method Subject Matter Expert, leading troubleshooting activities and utilizing root cause analysis tools like FMEA and 5 why's.
As a lead in the QC team, you will mentor junior members, peer review documentation, and drive the completion of laboratory investigation reports and deviations.
Matching Summary
This role involves performing and reviewing routine and non-routine testing to ensure compliance with corporate and regulatory requirements for biologics and vaccines.
Skills & Requirements
Must-have
HPLC system operation and software
cGMP and GLP compliance knowledge
Root cause analysis tools (FMEA, Fishbone)
Method transfer and validation support
OOS investigation leadership
Nice-to-have
Mentoring junior team members
Driving continuous improvement initiatives
Leading internal and external audits
Experience with cell-based assays
Strong data integrity focus
Key Requirements
Bachelor's degree in Analytical Chemistry or Biochemistry
2-3 years experience in pharmaceutical laboratory
Good working knowledge of HPLC systems
Knowledge of cGMP, GLP, and Quality Management Systems