Sterility Assurance Lead Jobs

This is where you save and sustain lives
At Baxter, we are deeply connected by our mission. No matter your role at Baxter, your work makes a positive impact on people around the world. You'll feel a sense of purpose throughout the organization, as we know our work improves outcomes for millions of patients.
Baxter's products and therapies are found in almost every hospital worldwide, in clinics and in the home. For over 85 years, we have pioneered significant medical innovations that transform healthcare.
Together, we create a place where we are happy, successful and inspire each other. This is where you can do your best work.
Join us at the intersection of saving and sustaining lives—where your purpose accelerates our mission.
Your Role:
In this role, you will be responsible for ensuring compliance of CIVA’s Sterility Assurance program with regulatory and Baxter Corporate requirements and applicable industry standards.
What you'll be doing:

• Manage audit readiness for Sterility Assurance, and host/participate in internal and external inspections
• Represent Sterility Assurance at CIVA in applicable forums (Global Compounding Sterility Assurance, Baxter Sterility Assurance Community of Practice)
• Ensure local SOPs are up to date and aligned with requirements and applicable regulatory standards
• Own change controls and author/complete validations related to new Sterility Assurance equipment, software and processes
• Set up and approve Novatek protocols
• Manage the Environmental Monitoring program and ensure compliance with applicable regulatory and corporate requirements.
• Update Microbial Control Scheme and Microbial Control Plan as the need arises
• Investigate all Sterility Assurance related exceptions (e.g. Micro OOLs, Particulate Matter OOLs, Qualification failures); coordinate and document follow-up actions
• Lead cross-functional teams in performing Environmental Performance Qualifications, Process Failure Modes and Effect Analysis, and Real Time Risk Assessment per requirements
• Identify and implement opportunities for improved testing procedures and/or equipment
• Prepare and maintain monthly and annual summaries of Sterility Assurance data, including trend reports
• Support Microbiologists and Micro Testers by providing mentorship and guidance
• Perform Sterility Assurance impact assessment for product and process changes

What you'll bring:

• Ability to building positive relationships
• Strong problem solving, critical thinking and analytical skills
• Ability to proactively initiate and implement continuous quality improvement
• Bachelor of Science - Pharmacy, Microbiology, Chemistry, Biology   
• 3 to 5 years' experience in compounding or aseptic manufacturing and GMP regulated industry
• Knowledge of parenteral products and their intended use
•  Experience leading teams, motivating or mentoring others
• Excellent written/verbal communication and organization skills
• Ability to prioritize multiple tasks and work autonomously
• Understanding of local regulatory requirements for compounding
•  Lean or Six Sigma
• Knowledge and application of computer systems for word processing, reporting, data analysis and NCR/CAPA, and Change Control Management
• Strong GMP knowledge and understanding of aseptic technique

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Reasonable Accommodations
Baxter is committed to working with and providing reasonable accommodations to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application or interview process, please send an e-mail to [email protected] and let us know the nature of your request along with your contact information.
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