Senior Microbiology Quality Sterility Assurance 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 jnj.com

As guided by Our Credo, Johnson & Johnson is responsible to our employees who work with us throughout the world.  We provide an inclusive work environment where each person is considered as an individual.  At Johnson & Johnson, we respect the diversity and dignity of our employees and recognize their merit.

Job Function:

Quality

Job Sub Function:

R&D/Scientific Quality

Job Category:

Professional

All Job Posting Locations:

Danvers, Massachusetts, United States of America

Job Description:

We are searching for the best talent for a Senior Microbiology Quality Sterility Assurance Scientist to be based in Danvers, MA.

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 

Purpose: The Sr. MQSA Scientist is responsible for supporting the Contamination Control, Environmental, Microbiology and Sterilizations programs and practices through the implementation of the appropriate Medical Device standards. The candidate will be a subject matter expert in these areas and coordinate all activities related to them across the organization.

You will be responsible for:

• Manages a workplace in compliance with regulatory or company requirements.
• Demonstrate ability to communicate to customers and management on schedules and processing timetables to ensure timely completion.
• Integrates new technologies and test methods into routine practice. Conducts technical assessments and qualifies suppliers and other contract services. Develop innovative ideas for sterilization/ aseptic processing of products not amenable to traditional methods.
• Interfaces with Regulatory Authorities during on-site inspections and related to submissions.
• Lead MQ&SA remediation activities for regulatory findings.
• Participation as SME in internal and external audits.
• Ensure compliance of the team for a safe working environment.
• Facilitates the timely testing of Environmental Monitoring Testing, BET, Bioburden, End Product Cleaning Testing and Annual Re-Qualification process for EO sterilization processes globally as required.
• Works with R&D, manufacturing, and quality to bring new products and changes to existing products to completion as the MQSA SME.
• Works with sterilization vendors to resolve any non-conformances.
• Prepare metrics and trending reports for Sr. Management as necessary.
• Provides direction regarding Corrective and Preventative Actions that relate to MQSA related topics.
• Interprets updates to applicable international standards and guidelines and implements them into the quality system.
• Helps establish formal escalation processes to surface issues of product quality, regulatory compliance, and quality systems.
• Coaches more junior colleagues in techniques, processes, and responsibilities.
• Develops complex subject matter expertise on R&D/Scientific Quality and assists in the review of policies that may impact organizational objectives.
• Designs systems to collect and test samples and prepares detailed observations to ensure conformity to physical and/or chemical specifications.
• Implement processes to ensure the internal organization's alignment with overall quality priorities.
• Is considered a J&J MQ&SA point of contact or a service leader within operating company supporting new and modified product/ process/packaging development and optimization.
• Support integration of new acquisitions, relative to MQSA.
• Other duties as required.

Qualifications/Requirements:

• Bachelor’s degree or equivalent required.
• 6 years of related work experience desired; Medical device experience preferred.
• Knowledge of lean, six sigma, kaizen and continuous improvement initiatives is a plus.
• Excellent verbal and written communication skills.
• Strong organizational skills; must be detailed-oriented.
• Ability to execute tasks in a timely manner independently.
• Strong knowledge of Microsoft Office Suite, and Adobe Acrobat.

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, please email the Employee Health Support Center  (ra-employeehealthsup@its.jnj.com) or contact AskGS to be directed to your accommodation resource.

Required Skills:

 

 

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 Control Testing, 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 period10 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