Senior Analyst, Quality Systems

Location: Raritan, New Jersey, United States of America

Salary: $79,000–$127,650 per year

Company

Johnson & Johnson MedTech develops healthcare and medical technology solutions as part of Johnson & Johnson’s global healthcare business.

What you will do

• Provide guidance and execute quality system activities, including document and records management and data integrity.
• Support the document lifecycle and perform superuser activities for the Raritan Advanced Therapies site.
• Act as a liaison between the Raritan site and platform-level or Innovative Medicine quality activities.
• Assist with audits, investigations, change controls, standard operating procedures, and related quality documentation.
• Identify quality system risks and improvement opportunities, escalating risks to senior management.
• Lead selected optimization projects through completion and improve alignment between local and global processes.

Requirements

• Bachelor’s degree in engineering, science, or an equivalent technical field.
• At least 4 years of related work experience in quality assurance or quality systems.
• Knowledge of cGMP regulations and FDA/EU guidance.
• Strong written and verbal communication skills in English.
• Strong collaboration and time management skills, with the ability to support a global environment.
• Ability and flexibility to provide occasional support during off-shift hours.

Nice to have

• Experience in a fast-paced manufacturing environment.

Culture & Benefits

• Inclusive work environment focused on employee dignity, diversity, and equal opportunity.
• Participation in pension and 401(k) savings plans, subject to plan terms.
• Vacation, sick time, holiday pay, parental leave, caregiver leave, bereavement leave, and volunteer leave.
• Support for work, personal, family, and military spouse time off.