Microbiological Quality & Sterility Assurance (MQSA), Staff Scientist

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at https://www.jnj.com

Job Function:

Quality

Job Sub Function:

R&D/Scientific Quality

Job Category:

Professional

All Job Posting Locations:

Raynham, Massachusetts, United States of America, Warsaw, Indiana, United States of America, West Chester, Pennsylvania, United States of America

Job Description:

Johnson & Johnson is recruiting for a Microbiological Quality & Sterility Assurance (MQSA), Staff Scientist. The preferred location is Raynham, MA. However, the job can also be based in West Chester, PA or Warsaw, IN.

About MedTech

Fueled by innovation at the intersection of biology and technology, we’re developing the next generation of smarter, less invasive, more personalized treatments.

Your unique talents will help patients on their journey to wellness. Learn more at https://www.jnj.com/medtech

Microbiological Quality & Sterility Assurance (MQSA), Staff Scientist position is responsible for end-to-end implementation of projects associated with microbiological quality and sterility assurance across the make and product development teams for Orthopedics and will ensure that those programs are aligned with the overall J&J Microbiological Quality & Sterility Assurance programs.

The Staff Scientist, MQSA, will serve as a technical leader in the areas of microbiological quality, sterilization, and reprocessing.  He/she may manage a team with partners to centrally support end to end microbiological quality.  He/she may set the strategic and tactical direction of the team through the application of technical knowledge and expertise in microbiological quality, and sterilization processing.  The position will also oversee partnerships for product development, make and the deliver quality organization.  This position is responsible for compliance to applicable quality regulations and standards and serves as the site subject matter expert for MQSA.

Key Responsibilities:

• Subject matter expert expertise on R&D/Scientific Quality and assists in the review of policies that may impact organizational objectives.
• Lead the design of new manufacturing processes, controlled environments and packaging for microbiological quality, terminal sterilization and reprocessing.
• Assists in the oversight and monitoring of laboratory experiments to test the physical and/or chemical specifications of various substances, materials, and product.
• Design systems to collect and test samples and prepare detailed observations to ensure conformity to physical and/or chemical specifications.
• Implement processes to ensure the internal organization’s alignment with overall quality priorities.
• Help establish formal escalation processes to surface issues of product quality, regulatory compliance, and quality systems.
• Delivers research related to areas such as microbiology and sterility.
• Coaches more junior colleagues in technique, processes, and responsibilities.
• Understands and applies Johnson & Johnson’s Credo and Leadership Imperatives in day-to-day interactions with team.

Qualifications

Education:

• University/Bachelors or equivalent degree in Microbiology, Biology, Engineering or related discipline is required.

Experience and Skills:

Required:

• A minimum of six (6) years of related experience in a medical device and/or pharmaceutical industry in a GMP and/or ISO regulated environment. 
• Manages a workplace in compliance with regulatory or company requirements.
• Is considered a J&J MQSA point of contact or a service leader within operating company supporting new and modified product/process/packaging development and optimization.
• Demonstrates ability to communicate science to line management on schedules and processing timetables to ensure timely completion.
• Integrates new technologies and test methods into routine practice. Conducts technical assessments, evaluates suppliers' other contract services.
• Develops innovative ideas for steril