Senior Microbiology Quality Sterility Assurance Scientist Full-time

Senior Microbiology Quality Sterility Assurance Scientist

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

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:

• Managing a workplace in compliance with regulatory or company requirements.
• Demonstrating ability to communicate to customers and management on schedules and processing timetables to ensure timely completion.
• Integrating new technologies and test methods into routine practice. Conducting technical assessments and qualifying suppliers and other contract services. Developing innovative ideas for sterilization/ aseptic processing of products not amenable to traditional methods.
• Interfacing with Regulatory Authorities during on-site inspections and related to submissions.
• Leading MQ&SA remediation activities for regulatory findings.
• Participation as SME in internal and external audits.
• Ensuring compliance of the team for a safe working environment.
• Facilitating 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.
• Working with R&D, manufacturing, and quality to bring new products and changes to existing products to completion as the MQSA SME.
• Working with sterilization vendors to resolve any non-conformances.
• Preparing metrics and trending reports for Sr. Management as necessary.
• Providing direction regarding Corrective and Preventative Actions that relate to MQSA related topics.
• Interpreting updates to applicable international standards and guidelines and implementing them into the quality system.
• Helping establish formal escalation processes to surface issues of product quality, regulatory compliance, and quality systems.
• Coaching more junior colleagues in techniques, processes, and responsibilities.
• Developing complex subject matter expertise on R&D/Scientific Quality and assisting in the review of policies that may impact organizational objectives.
• Designing systems to collect and test samples and preparing detailed observations to ensure conformity to physical and/or chemical specifications.
• Implementing processes to ensure the internal organization's alignment with overall quality priorities.
• Being 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.
• Supporting 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 detail-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.

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