The QA Specialist II partners with cross-functional teams to execute validation activities for cGMP pharmaceutical manufacturing across multiple facilities
Job Summary
The QA Specialist II partners with cross-functional teams to execute validation activities for cGMP pharmaceutical manufacturing across multiple facilities.
This role requires reviewing and approving validation plans, protocols, and reports without supervision while ensuring regulatory compliance.
The position offers the opportunity to drive continuous improvement initiatives and mentor less experienced team members within a global network.
Matching Summary
The QA Specialist II partners with cross-functional teams to execute validation activities for cGMP pharmaceutical manufacturing across multiple facilities.
Skills & Requirements
Must-have
Bachelor's Degree in scientific discipline
5+ years pharmaceutical industry experience
1+ year QA Operations role
cGMP compliance knowledge FDA EU ICH
Equipment and process validation expertise
Nice-to-have
ASQ certification preferred
Thermal characterization and vacuum physics
Aseptic filling and lyophilization experience
Risk-based decision making skills
Mentoring junior team members
Key Requirements
Bachelor's degree in relevant scientific discipline
Minimum 5 years pharmaceutical or biotech experience