Lead Sterility Assurance Specialist at Baxter

Shape healthcare standards at Baxter as the Lead Sterility Assurance Specialist. Ensure compliance and lead initiatives that impact lives across the globe in a GMP regulated environment.

In this pivotal role, you will oversee CIVA's Sterility Assurance program, ensuring alignment with Baxter Corporate standards and regulatory requirements. With 3-5 years of experience in a GMP setting, you will investigate sterility assurance exceptions and direct the Environmental Monitoring program. This role requires strong leadership and mentorship capabilities, alongside analytical and problem-solving skills.

Key Responsibilities:

• Ensure compliance with sterility assurance and regulatory requirements

• Direct and maintain the Environmental Monitoring program

• Represent sterility assurance at forums and practice communities

• Investigate all sterility assurance-related exceptions

• Lead cross-functional performance qualifications and risk assessments

Requirements:

• Bachelor of Science in Pharmacy, Microbiology, Chemistry, or Biology

• 3-5 years of relevant GMP industry experience

• Strong understanding of aseptic techniques and GMP

• Excellent problem-solving and analytical abilities

• Experience in clean rooms and aseptic processing preferred

Join Baxter to drive quality and compliance in healthcare delivery through your expertise in sterility assurance.