Senior Quality Systems Analyst: Global Impact & Compliance

6062-Janssen Pharmaceuticals, Inc. Legal Entity; Raritan Township (ND); On-site; USD 79,000 - 128,000; Full time

Job summary

Johnson & Johnson in Raritan, NJ is seeking a Senior Analyst, Quality Systems to lead and execute quality system activities, including document/records management and data integrity, ensuring compliance with cGMP and FDA/EU guidance.

You will liaise with the AT site and global platforms, support the document lifecycle, act as a superuser, elevate quality risks to management, and contribute to audits, investigations, and change controls while driving process improvements.

Qualifications

• Bachelor's degree in engineering, science or equivalent technical subject
• Minimum 4 years of related work experience
• Experience in Quality Assurance/Quality Systems
• Strong written and verbal communication skills in English
• Ability to work in and support a global environment

Responsibilities

• Provide preliminary guidance and execute quality system activities, including but not limited to Document/Records Management and Data Integrity.
• Act as a liaison between Raritan Advanced Therapies (AT) site and AT platform/Innovative Medicine level activities.
• Support document lifecycle at Raritan AT.
• Perform Raritan AT superuser activities.
• Elevate identified quality systems risks to senior management.
• Perform tasks in a manner consistent with the safety policies, quality systems and cGxP requirements.
• Actively assist in audit activities, Investigations and Change Controls.
• Identify improvement opportunities for quality systems activities.
• Participate in department optimization effort, take the lead on selected projects assignments following them through closure.
• Update Standard Operating Procedures or related documents as needed.
• Drive alignment and efficiencies between local and global processes through building positive relationships to meet unified business objectives.

Skills

Quality Systems

cGMP

FDA/EU guidance

English communication

Cross-functional collaboration

Time management

Education

Bachelor's degree in engineering/science

Job description

Johnson & Johnson in Raritan, NJ is seeking a Senior Analyst, Quality Systems to lead and execute quality system activities, including document/records management and data integrity, ensuring compliance with cGMP and FDA/EU guidance.

You will liaise with the AT site and global platforms, support the document lifecycle, act as a superuser, elevate quality risks to management, and contribute to audits, investigations, and change controls while driving process improvements.