Senior Analyst, Quality Systems

About the role

Johnson & Johnson is recruiting for a Senior Analyst, Quality Systems located in Raritan, New Jersey. The role supports quality system activities for the Raritan Advanced Therapies site, acts as a liaison with platform/Innovative Medicine activities, and drives alignment between local and global processes.

Responsibilities

• Provide preliminary guidance and execute quality system activities, including 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 consistent with safety policies, quality systems and cGxP requirements.
• Assist in audit activities, investigations and change controls.
• Identify improvement opportunities for quality systems activities.
• Participate in department optimization effort, lead selected projects 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.
• Other duties as assigned to support business continuity.

Qualifications

• Education: Minimum of a bachelor’s degree in engineering, Science or equivalent technical subject area.
• Experience: Minimum 4 years of related work experience in Quality Assurance/Quality Systems.
• Knowledge: cGMP regulations and FDA/EU guidance.
• Skills: Strong written and verbal communication skills in English; strong collaboration and time management skills; ability to work in and support a global environment.
• Preferred: Experience in a highly paced manufacturing environment.
• Other: Ability and flexibility to provide occasional support at off‑shift hours.

Benefits

• Vacation – 120 hours per calendar year.
• Sick time – 40 hours per calendar year (48 hours for Colorado residents; 56 hours for Washington residents).
• 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 birth/adoption/foster care.
• 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.
• Retirement: eligibility to participate in the Company’s consolidated retirement plan (pension) and savings plan (401(k)).

Pay

The anticipated base pay range for this position is $79,000.00 – $127,650.00.