Senior Analyst, Quality Systems (MQSA)

At Johnson & Johnsonwe believe health is everything. Our strength in healthcare innovation empowers us to build aworld where complex diseases are prevented treated and curedwhere treatments are smarter and less invasive andsolutions are 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 more at

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:

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 were 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 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 crossfunctional partners to support audit readiness data integrity and continuous improvement activities within a clearly defined scope. This role does not have peoplemanagement 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 procedurealigned.

• 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:

• Bachelors 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 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 :

$79000.00 - $127650.00

Additional Description for Pay Transparency:

Subject to the terms of their respective plans employees are eligible to participate in the Companys 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: - Experience:

Senior IC