Smith & Nephew is seeking a Senior Quality Control Analyst & Investigator with extensive experience in laboratory investigations within the pharmaceutical or biotech industry. The successful candidate will lead investigations for quality control issues, ensuring compliance with FDA regulations in a sterile manufacturing environment, while promoting collaboration among cross-functional teams
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 hybrid work model, 401k matching, tuition reimbursement, and comprehensive benefits including health savings accounts and parental leave.
Matching Summary
Match Score: 85
Smith & Nephew is seeking a Senior Quality Control Analyst & Investigator with extensive experience in laboratory investigations within the pharmaceutical or biotech industry. The successful candidate will lead investigations for quality control issues, ensuring compliance with FDA regulations in a sterile manufacturing environment, while promoting collaboration among cross-functional teams.
Skills & Requirements
Must-have
8-10 years QC pharmaceutical experience
FDA OOS guidance expertise
Root cause analysis tools (5 Whys, Fishbone)
Sterile drug product manufacturing knowledge
CAPA development and implementation
Analytical chemistry and instrumentation
Investigation report documentation
Nice-to-have
Regulatory inspection SME support
Aseptic processing quality expectations
Cross-functional team collaboration
Coaching and guidance to analysts
Scientifically justified retest strategies
Key Requirements
8-10 years of Quality Control experience
Bachelor's or advanced degree in Chemistry or related field
Deep knowledge of FDA OOS guidance and cGMPs
Experience with sterile manufacturing environments