Quality Systems Analyst: Documentation & Compliance Lead

Biopharma Careers; Raritan (NJ); On-site; USD 65,000 - 105,000; Full time

Benefits offered by this job

Pension plan

401(k) plan

Paid time off

Job summary

Johnson & Johnson is seeking an Analyst, Quality Systems, in Raritan, NJ to join the Quality Documentation team onsite. You will manage document control, data integrity and change control activities while partnering with site and global stakeholders to ensure cGMP compliance and reliable quality systems.

Requirements include a bachelor’s degree in engineering or science, at least 2 years in QA/QMS roles, strong English communication, and proven collaboration and time-management skills.

Qualifications

• Bachelor’s degree in engineering, science, or equivalent
• Minimum 2 years of work experience in Quality Assurance/Quality Systems/Quality Control
• Knowledge of cGMP regulations
• Strong written and verbal communication in English
• Experience in a highly paced manufacturing environment

Responsibilities

• Complete quality system execution activities, including document/records management and Data Integrity
• Act as a liaison between site and above-site activities
• Support document lifecycle and perform site superuser activities
• Identify improvement opportunities and elevate potential risks to management
• Actively assist in Audit, Investigation and Change Control related activities
• Participate in department optimization efforts
• Take the lead on selected projects assignments following them through closure
• Update Standard Operating Procedures and related documents
• Drive alignment and efficiencies between local and global processes
• Perform tasks in a manner consistent with safety policies and cGxP requirements
• Provide occasional support at off-shift hours with little or no prior notice
• Other duties can be assigned to support business continuity

Skills

Quality Assurance

cGMP knowledge

Verbal communication

Collaboration

Time management

Education

Bachelor’s degree in engineering or science

Job description

Johnson & Johnson is seeking an Analyst, Quality Systems, in Raritan, NJ to join the Quality Documentation team onsite. You will manage document control, data integrity and change control activities while partnering with site and global stakeholders to ensure cGMP compliance and reliable quality systems.

Requirements include a bachelor’s degree in engineering or science, at least 2 years in QA/QMS roles, strong English communication, and proven collaboration and time-management skills.