Senior Analyst, Quality Systems - (MQSA)

Johnson & Johnson Innovative Medicine • Raritan, NJ

2d • Onsite

About The Position

The Senior Analyst, Quality Systems supports the execution of the MedTech Quality Management System (QMS) within a regulated environment, with a focus on Microbiological Quality & Sterility Assurance (MQSA) activities. This includes microbiological testing, laboratory services, and sterility assurance records. The role 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. The Analyst collaborates with cross-functional partners to support audit readiness, data integrity, and continuous improvement activities within a defined scope. This role does not have people-management responsibility and advances issues and risks in accordance with established procedures.

Requirements

• Bachelor’s degree in Science, Microbiology, Biology, Engineering, Quality, or a related technical discipline is 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.
• 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.

Nice To Haves

• Familiarity with ISO 17025 requirements (where applicable) is a plus.
• 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.

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.

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
• Volunteer Leave – 32 hours per calendar year
• Military Spouse Time-Off – 80 hours per calendar year

What This Job Offers

• Job Type: Full-time
• Career Level: Senior