Principal Associate - Sterility Assurance
Welcome to Baxter International, a global leader in healthcare solutions. We are seeking a highly skilled and experienced Principal Associate in Sterility Assurance to join our team. In this role, you will play a crucial role in ensuring the safety and effectiveness of our products by leading the sterilization validation process. If you are passionate about making a positive impact on patient care and have a strong background in sterility assurance, we want to hear from you. Join us in our mission to save and sustain lives.
- Lead the sterilization validation process for all products at Baxter International.
- Develop and implement sterilization validation protocols and procedures in accordance with industry standards and regulations.
- Review and analyze data from sterilization validation studies to ensure compliance with regulatory requirements.
- Collaborate with cross-functional teams to ensure proper implementation and execution of sterilization protocols.
- Stay up-to-date with industry developments and regulations related to sterility assurance and make necessary recommendations for process improvements.
- Conduct risk assessments and root cause analysis for any sterilization-related issues and provide solutions and recommendations.
- Train and mentor junior team members on sterilization validation processes and procedures.
- Maintain accurate documentation and records of all sterilization validation activities.
- Work closely with quality assurance and regulatory teams to ensure compliance with all applicable regulations and standards.
- Participate in audits and inspections related to sterility assurance and provide necessary support and documentation.
- Continuously monitor and evaluate the effectiveness of sterilization processes and make recommendations for improvements.
- Communicate and collaborate with external partners, vendors, and regulatory bodies as needed.
- Act as a subject matter expert and provide guidance and support to other departments on matters related to sterility assurance.
- Adhere to all safety protocols and procedures to ensure a safe working environment.
Extensive Knowledge Of Sterility Assurance Principles: The Ideal Candidate Should Possess A Thorough Understanding Of Aseptic Processing And Sterility Assurance Principles, Including Aseptic Technique, Environmental Monitoring, And Sterilization Methods.
Experience In Pharmaceutical Manufacturing: The Candidate Should Have At Least 5 Years Of Experience In A Pharmaceutical Manufacturing Environment, With A Focus On Sterile Products. This Should Include Experience In Process Development, Validation, And Quality Control.
Regulatory Compliance: The Candidate Must Have A Strong Understanding Of Current Good Manufacturing Practices (Cgmp) And Regulatory Requirements For Sterile Products, Including Fda, Ema, And Other Global Regulatory Agencies.
Leadership And Team Management Skills: The Candidate Must Have Proven Leadership Skills And Experience In Managing A Team. They Should Be Able To Effectively Communicate, Delegate Tasks, And Motivate Team Members To Achieve Goals.
Problem-Solving And Analytical Skills: The Candidate Should Have Strong Problem-Solving And Analytical Skills To Identify And Resolve Issues Related To Sterility Assurance. They Should Also Be Able To Analyze Data And Propose Solutions To Improve Processes And Procedures.
Validation
Quality Control
Root Cause Analysis
Compliance
Risk assessment
Microbiology
Environmental monitoring
aseptic techniques
Audit Preparation
Sterility Assurance
Gmp Regulations
Communication
Conflict Resolution
Decision Making
Emotional Intelligence
Leadership
Problem Solving
Time management
creativity
Teamwork
Adaptability
According to JobzMall, the average salary range for a Principal Associate - Sterility Assurance in Marion, NC 28752, USA is $95,000-$130,000 per year. However, this can vary depending on factors such as experience, education, and the specific company or organization.
Apply with Video Cover Letter Add a warm greeting to your application and stand out!
Baxter International Inc. is a Fortune 500 American health care company with headquarters in Deerfield, Illinois. The company primarily focuses on products to treat hemophilia, kidney disease, immune disorders and other chronic and acute medical conditions.
Get interviewed today!
JobzMall is the world‘ s largest video talent marketplace.It‘s ultrafast, fun, and human.
Get Started