Staff Scientist Microbiology Quality & Sterility Assurance (MQSA), Orthopedics Full-time

Staff Scientist Microbiological Quality & Sterility Assurance (MQSA)

Johnson & Johnson is recruiting for a Staff Scientist Microbiological Quality & Sterility Assurance (MQSA), located in Raynham, MA or Warsaw, IN.

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.

The 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.
• Lead J&J MQ&SA as a point of contact or a service leader within operating company supporting new and modified product/process/packaging development and optimization.

Qualifications

Education:

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

Experience and Skills:

Required:

• A minimum of 4-6 years of related experience in a medical device and/or pharmaceutical industry in a GMP and/or ISO regulated environment.
• Experience managing a workplace in compliance with regulatory or company requirements.
• Ability to communicate science to line management on schedules and processing timetables to ensure timely completion.
• Demonstrate strong technical knowledge in microbiological testing and requirements: including cleaning validations, sterilization validations, routine microbiological and chemical contamination control requirements and reprocessing requirements for medical devices.
• Experience integrating new technologies and test methods into routine practice.
• Conducts technical assessments, evaluates suppliers' other contract services.
• Develop innovative ideas for process improvements.
• Interface with Regulatory Authorities during on-site inspections related to submissions.
• Lead MQ&SA remediation activities from audit findings.
• Participate as SME in audits internal/external.
• Ensure compliance with the team for a safe working environment.
• Support integration of new acquisitions relative to MQSA.
• Manage processes across multiple quality management systems to support the business.
• Demonstrates strong people leader and business acumen, this position may have direct reports.

Other:

• Proficiency in the English language (oral and written) is required.
• Up to 10% domestic or international travel is required.

Johnson & Johnson is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, disability, protected veteran status or other characteristics protected by federal, state or local law. We actively seek qualified candidates who are protected veterans and individuals with disabilities as defined under VEVRAA and Section 503 of the Rehabilitation Act.

Johnson & Johnson is committed to providing an interview process that is inclusive of our applicants' needs. If you are an individual with a disability and would like to request an accommodation, external applicants please contact us via

https://www.jnj.com/contact-us/careers

Internal employees contact AskGS to be directed to your accommodation resource.

#LI-Hybrid

Required Skills: Accelerating, Agility Jumps, Coaching, Communication, Compliance Management, Continuous Improvement, Data Savvy, Disaster Recovery (DR), Econometric Models, Issue Escalation, Problem Solving, Product Improvements, Quality Control (QC), Quality Management Systems (QMS), Quality Standards, Regulatory Environment, Researching

Preferred Skills: Accelerating, Agility Jumps, Coaching, Communication, Compliance Management, Continuous Improvement, Data Savvy, Disaster Recovery (DR), Econometric Models, Issue Escalation, Problem Solving, Product Improvements, Quality Control (QC), Quality Management Systems (QMS), Quality Standards, Regulatory Environment, Researching

The anticipated base pay range for this position is: $109,000.00 – $174,800.00

Additional Description for Pay Transparency:

Subject to the terms of their respective plans, employees are eligible to participate in the Company's consolidated retirement plan (pension) and savings plan (401(k)). Subject to the terms of their respective policies and date of hire, employees are eligible for the following time off benefits: Vacation –120 hours per calendar year Sick time – 40 hours per calendar year; for employees who reside in the State of Colorado –48 hours per calendar year; for employees who reside in the State of Washington –56 hours per calendar year Holiday pay, including Floating Holidays –13 days per calendar year Work, Personal and Family Time – up to 40 hours per calendar year Parental Leave – 480 hours within one year of the birth/adoption/foster care of a child Bereavement Leave – 240 hours for an immediate family member: 40 hours for an extended family member per calendar year Caregiver Leave – 80 hours in a 52-week rolling period 10 days Volunteer Leave – 32 hours per calendar year Military Spouse Time-Off – 80 hours per calendar year For additional general information on Company benefits, please go to: – https://www.careers.jnj.com/employee-benefits