The Senior QC Analyst & Investigator is responsible for leading thorough, compliant laboratory investigations within a sterile drug product manufacturing environment
Job Summary
The Senior QC Analyst & Investigator is responsible for leading thorough, compliant laboratory investigations within a sterile drug product manufacturing environment.
This role requires deep expertise in identifying true root causes and preventing recurrence through effective CAPA development while ensuring all investigations meet FDA expectations.
Smith+Nephew offers a comprehensive benefits package including 401k matching, flexible work models, and extensive employee wellbeing programs.
Matching Summary
The Senior QC Analyst & Investigator is responsible for leading thorough, compliant laboratory investigations within a sterile drug product manufacturing environment.
Skills & Requirements
Must-have
8-10 years QC pharmaceutical experience
FDA OOS guidance and cGMP knowledge
Root cause analysis tools expertise
Sterile drug product environment experience
CAPA development and implementation
Nice-to-have
Regulatory inspection SME support
Cross-functional collaboration skills
Coaching and mentoring capabilities
Scientifically justified retest strategies
Key Requirements
8-10 years of Quality Control experience
Bachelor's or advanced degree in Chemistry or related field
US citizenship or permanent residency required (no sponsorship)