Sterility Assurance Lead - Day shift (Monday to Friday 8:00-17:30)
Baxter · Mississauga, Canada
QualityFull-time$86k–$130kCompany career page
The apply link worked recently (not employer-confirmed).
Role summary
Baxter seeks a Sterility Assurance Lead in Mississauga to oversee compliance and advancement of sterility and environmental monitoring programs in a GMP-regulated manufacturing setting. The role involves directing cross-functional teams, investigating exceptions, and maintaining alignment with regulatory standards.
What they're looking for
- Bachelor of Science in Pharmacy, Microbiology, Chemistry, or Biology
- 3–5 years experience in GMP regulated industry
- Strong aseptic technique and GMP knowledge
- Problem-solving, critical thinking, and analytical skills
- Ability to prioritize multiple tasks and work autonomously
- Technical expertise in cleanrooms and aseptic processing (preferred)
- Team leadership and mentorship experience (preferred)
What you'll be doing
- Ensure Sterility Assurance program compliance with regulatory and corporate requirements
- Direct Environmental Monitoring program and maintain applicable standard alignment
- Investigate and document Sterility Assurance related exceptions
- Lead cross-functional teams in Environmental Performance Qualifications and Real Time Risk Assessments
- Update and maintain Microbial Control Scheme, Plan, and local standard operating procedures
Privacy & handoff
This role links to Baxter's own application system. RoleLantern records your interest and checks the link, but the application happens on the employer's site and status updates may not come back to us. Clicking apply does not mark you as applied automatically.