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**Job Function: **
Quality
**Job Sub Function: **
Quality Assurance
Job Category:
Professional
All Job Posting Locations:
Raritan, New Jersey, United States of America
Job Description:
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
We are seeking for a Senior Analyst, Quality Systems to support Microbiological Quality and Sterility Assurance (MQSA) to be located in Raritan, NJ.
The Johnson & Johnson Microbiological Quality and Sterility Assurance (JJMQSA) organization is located on the Raritan campus in Building 930 East. JJMQSA provides testing services for MedTech and Innovative Medicine sites to support contamination control requirements, including process/test method development, manufacturing capabilities, and investigations.
Services include custom protocols and program-specific studies. Testing capabilities cover sterilization feasibility and process development (e.g., ethylene oxide, moist heat, dry heat), use of biological indicators (population verification, sterilization process development, and BI sterility), cleaning disinfection, and moist heat sterilization validations for reusable medical devices.
Manufacturing capabilities to support contamination control requirements includes surface disinfection efficacy testing, surface/equipment cleaning validation, environmental monitoring, and sterilization of manufacturing supplies. Investigational testing may include compendial methods such as bioburden, bacteriostasis/fungistasis, bacterial endotoxin, growth promotion, microbial identification, and microorganism library storage, etc.
Job Summary
The Senior Analyst, Quality System supports execution of the Med Tech Quality Management System (QMS) within a regulated environment, with a focus on Microbiological Quality & Sterility Assurance (MQSA) activities, including microbiological testing, laboratory services, and sterility assurance records.
In this role, the Analyst supports Quality System processes related to documentation, records, data integrity, and training, ensuring compliance with applicable regulatory requirements such as FDA, ISO, GxP, and ISO 17025 (where applicable).
The Analyst collaborates with cross‑functional partners to support audit readiness, data integrity, and continuous improvement activities within a clearly defined scope. This role does not have people‑management responsibility and advances issues and risks in accordance with established procedures.
Key Responsibilities
- Support execution of assigned Quality Management System (QMS) processes in compliance with Ethicon and Johnson & Johnson policies, procedures, and applicable regulatory requirements (e.g., FDA, ISO, GxP).
- Complete assigned Quality System tasks within a defined scope, ensuring work is accurate, timely, and aligned with established procedures.
- Apply working knowledge of the QMS and follow documented workflows to support daily activities, advancing issues, deviations, or questions as required.
- Support audit and inspection readiness by maintaining accurate documentation, records, and supporting evidence in accordance with procedural requirements.
- Support compliance activities in regulated laboratory environments, including microbiological testing and sterility assurance, by following established Quality System procedures and requirements.
- Apply assigned regulatory and procedural requirements to Quality System tasks, identifying and advancing compliance concerns or risks to Quality leadership as appropriate.
- Assist with deviation, nonconformance, and CAPA activities by preparing documentation, performing assigned checks, and ensuring records are complete, accurate, and procedure‑aligned.
- Support a culture of quality and compliance through disciplined task execution, adherence to documented processes, and timely communication of issues or uncertainties.
- Support document lifecycle activities within the electronic document management system (eDMS), including document creation, review coordination, routing, periodic review, and archival, with a focus on MQSA and laboratory related procedures, work instructions, forms, and records.
- Assist with review of quality and GxP documentation by performing assigned checks for completeness, accuracy, and compliance with formatting and procedural requirements, route documents through established review and approval workflows.
- Support quality and compliance checks on controlled documents, records, and service related documentation by verifying required content, metadata, and approvals prior to release.
- Maintain assigned document templates, trackers, and system tools to support standardization, consistency, and effective document control.
- Support audit and inspection readiness activities by ensuring assigned documentation, records, and training evidence are current, complete, and maintained.
- Participate in internal audits, external audits, and regulatory inspections by retrieving requested documentation, organizing records, and assisting with clarification of information.
- Track assigned audit observations and action items using established tools and processes and support timely updates and closure activities.
- Advance identified gaps, missing documentation, or compliance concerns to supervisors in accordance with established escalation pathways.
- Support Quality System training execution by assisting with updates and maintenance of training materials to ensure alignment with current approved procedures, including MQSA laboratory work instructions and sterility assurance
- documentation.
- Support audit and inspection readiness by ensuring required training records and evidence are accurate, complete, and readily retrievable.
- Support Quality System and compliance metrics by collecting, organizing, and maintaining assigned data, records, and reports.
- Assist with identification of trends, gaps, or potential issues through assigned data reviews and analysis.
- Participate in continuous improvement initiatives by completing assigned tasks and supporting documentation updates in accordance with approved improvement plans.
- Maintain accurate records and supporting evidence for quality metrics and improvement activities to support audit and inspection readiness.
**Qualifications **
** Education:**
- Bachelor’s degree in Science, Microbiology, Biology, Engineering, Quality, or a related technical discipline is required.
Experience/Skills
** Required:**
- A minimum of 4 years of related work experience.
- Experience supporting Quality Systems or compliance activities in a regulated environment such as MedTech, pharmaceutical, biotechnology, or laboratory operations.
- Exposure to Quality Management System (QMS) processes, including document control, training, records management, audits, CAPA, or change control.
- Experience following standard operating procedures (SOPs) and working within defined processes under appropriate supervision.
- Foundational knowledge of applicable regulatory and quality standards, including FDA regulations, ISO standards, and GxP principles.
- Familiarity with ISO 17025 requirements (where applicable) is a plus.
- Understanding data integrity and documentation requirements in regulated environments.
- Experience using electronic Quality systems, such as Electronic Document Management Systems (eDMS), Learning Management Systems (LMS), and other QMS related tools or databases.
- Proficiency with Microsoft Office applications, including Word, Excel, and Outlook.
- Strong attention to detail and organizational skills.
- Ability to follow established procedures and execute assigned tasks accurately.
- Clear written and verbal communication skills.
- Willingness to learn and develop Quality System and regulatory knowledge.
** Preferred: **
- Experience supporting or interacting with laboratory, microbiological testing, or sterility assurance activities.
- Exposure to microbiological laboratories, sterility assurance, or laboratory quality systems.
- Previous experience assisting with audits, inspections, or regulatory readiness activities.
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.
Required Skills:
Preferred Skills:
Business Alignment, Business Behavior, Coaching, Compliance Management, Continuous Improvement, Data Analysis, Detail-Oriented, Goal Attainment, Human-Centered Design, Internal Controls, Issue Escalation, Problem Solving, Process Oriented, Quality Control (QC), Quality Management Systems (QMS), Quality Standards
The anticipated base pay range for this position is :
$79,000.00 - $127,650.00
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