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

Microbiological Quality & Sterility Assurance (MQSA), Staff Scientist

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.

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.

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 sterile/aesthetic processing of products not amenable for traditional methods.
• Interfaces with Regulatory Authorities during on-site inspections related to submissions.
• Leads MQSA remediation activities from audit findings.
• Participates as SME in audits internal/external.
• Ensure compliance with the team for a safe working environment.
• Supports integration of new acquisitions relative to MQSA.
• Manage processes across multiple quality management systems to support the business.

Other:

• Proficiency in the English language (oral and written) is required.
• Up to 20% 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

The anticipated base pay range for this position is: $91,000-$147,200

Additional Description for Pay Transparency:

• The expected base pay range for this position is
• The expected base pay range for this position, in the Bay Area, is
• The Company maintains highly competitive, performance-based compensation programs.
• Under current guidelines, this position is eligible for an annual performance bonus in accordance with the terms of the applicable plan.
• The annual performance bonus is a cash bonus intended to provide an incentive to achieve annual targeted results by rewarding for individual and the corporation's performance over a calendar/performance year.
• Bonuses are awarded at the Company’s discretion on an individual basis.
• Employees and/or eligible dependents may be eligible to participate in the following Company sponsored employee benefit programs: medical, dental, vision, life insurance, short- and long-term disability, business accident insurance, and group legal insurance.
• Employees may be eligible to participate in the following time off benefits:
• Vacation – up to 120 hours per calendar year
• Sick time – up to 40 hours per calendar year; for employees who reside in the State of Washington – up to 56 hours per calendar year
• Holiday pay, including Floating Holidays – up to 13 days per calendar year
• Work, Personal and Family Time – up to 40 hours per calendar year

Additional information can be found through the link below. For additional general information on Company benefits, please go to: https://www.careers.jnj.com/employee-benefits

The compensation and benefits information set forth in this posting applies to candidates hired in the United States. Candidates hired outside the United States will be eligible for compensation and benefits in accordance with their local market.