Sterility Assurance Lead - Day shift (Monday to Friday 8:00-17:30)
usd86.4k - usd129.6k per yearBaxter
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.
Responsibilities
- 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
Requirements
- 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)
Compensation: $86,400–$129,600 annually, including base salary and estimated target Management Incentive Compensation Plan payout
Vacancy posted 5 days ago
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