Sr. Scientist- MQSA (Supplier/EM)
Johnson & Johnson MedTech · Palm Beach Gardens, FL · 1 wk ago
HybridManagement$92k–$148k/yrFull-time
Job Function
Quality
Job Sub Function
R&D/Scientific Quality
Job Category
Professional
- All Job Posting Locations
- Palm Beach Gardens, Florida, United States of America
- Raynham, Massachusetts, United States of America
- Warsaw, Indiana, United States of America
- West Chester, Pennsylvania, United States of America
About the Role
You will be responsible for:
- Supporting end-to-end Microbiological Quality & Sterility Assurance (MQ&SA) activities related to suppliers and external manufacturing processes
- Contributing to change requests and projects impacting controlled environments, cleaning, and sterilization processes
- Supporting contamination control strategies, including environmental monitoring and investigation activities
- Providing technical guidance and training on microbiological quality and sterility assurance
- Acting as subject matter expert for investigations, CAPA, non-conformances, audit observations, and risk assessments
- Supporting due diligence activities (e.g., acquisitions, partnerships) by providing MQ&SA expertise and risk input
- Supporting development and updates of supplier quality agreements
- Coeordinating and participating in supplier audits, including preparation, on-site support, response review, and follow-up activities
- Partnership with cross-functional teams to support supplier qualification and lifecycle management
- Contributing to remediation activities following audits or regulatory findings
- Building strong relationships with external partners, including manufacturers, suppliers, sterilization providers, and testing laboratories
Responsibilities
You will be responsible for:
- Supporting end-to-end Microbiological Quality & Sterility Assurance (MQ&SA) activities related to suppliers and external manufacturing processes
- Contributing to change requests and projects impacting controlled environments, cleaning, and sterilization processes
- Supporting contamination control strategies, including environmental monitoring and investigation activities
- Providing technical guidance and training on microbiological quality and sterility assurance
- Acting as subject matter expert for investigations, CAPA, non-conformances, audit observations, and risk assessments
- Supporting due diligence activities (e.g., acquisitions, partnerships) by providing MQ&SA expertise and risk input
- Supporting development and updates of supplier quality agreements
- Coeordinating and participating in supplier audits, including preparation, on-site support, response review, and follow-up activities
- Partnership with cross-functional teams to support supplier qualification and lifecycle management
- Contributing to remediation activities following audits or regulatory findings
- Building strong relationships with external partners, including manufacturers, suppliers, sterilization providers, and testing laboratories
Requirements
- A minimum of a Bachelor’s Degree in Microbiology, Biological Sciences or Engineering is required
- Minimum 4 years of experience with microbiological and sterilization in the medical device and/or pharmaceutical industry is preferred
- Strong knowledge of microbiological control, contamination control, and sterilization processes
- Familiarity with applicable standards and regulations (e.g., ISO, EN, AAMI)
- Experience conducting or supporting investigations, test method development, and validation
- Knowledge of regulatory and quality requirements related to suppliers and external manufacturing
- Experience supporting audits, inspections, or compliance assessments
- Strong communication and collaboration skills, with the ability to work across functions and levels
- Ability to work independently while contributing effectively to team objectives
- Fluent in English (Spanish is a plus)
- Demonstrates an understanding of AI concepts and frameworks, including awareness of responsible and ethical AI practices, and uses effective prompting techniques to support efficiency and productivity
Qualifications
- A minimum of a Bachelor’s Degree in Microbiology, Biological Sciences or Engineering is required
- Minimum 4 years of experience with microbiological and sterilization in the medical device and/or pharmaceutical industry is preferred
- Strong knowledge of microbiological control, contamination control, and sterilization processes
- Familiarity with applicable standards and regulations (e.g., ISO, EN, AAMI)
- Experience conducting or supporting investigations, test method development, and validation
- Knowledge of regulatory and quality requirements related to suppliers and external manufacturing
- Experience supporting audits, inspections, or compliance assessments
- Strong communication and collaboration skills, with the ability to work across functions and levels
- Ability to work independently while contributing effectively to team objectives
- Fluent in English (Spanish is a plus)
- Demonstrates an understanding of AI concepts and frameworks, including awareness of responsible and ethical AI practices, and uses effective prompting techniques to support efficiency and productivity
Skills
- Agility
- Jumps
- Business Behavior
- Coaching
- Compliance Management
- Continuous Improvement
- Data Savvy
- Disruptive Innovations
- Issue Escalation
- Problem Solving
- Process Oriented
- Product Improvements
- Quality Control (QC)
- Quality Control Testing
- Quality Management Systems (QMS)
- Quality Standards
- Regulatory Environment
- Report Writing
Pay
The anticipated base pay range for this position is: $92,000.00 - $148,350.00
Benefits
For additional general information on Company benefits, please go to: https://www.careers.jnj.com/employee-benefits