Senior Analyst, Quality Systems

Johnson & Johnson•Raritan, NJ

10d•Onsite

About The Position

Johnson & Johnson is currently recruiting for a Senior Analyst, Quality Systems. This position will be located in Raritan, NJ. The role involves providing preliminary guidance and executing quality system activities, including Document/Records Management and Data Integrity. The Senior Analyst will act as a liaison between the Raritan Advanced Therapies (AT) site and AT platform/Innovative Medicine level activities, supporting document lifecycle and performing Raritan AT superuser activities. The position requires elevating identified quality systems risks to senior management, performing tasks in a manner consistent with safety policies, quality systems, and cGxP requirements. Additionally, the role involves assisting in audit activities, investigations, and change controls, identifying improvement opportunities for quality systems, and participating in department optimization efforts, potentially leading selected projects to closure. The Senior Analyst will also update Standard Operating Procedures or related documents as needed and drive alignment and efficiencies between local and global processes by building positive relationships to meet unified business objectives. Other duties may be assigned to support business continuity.

Requirements

Minimum of a bachelor’s degree in engineering, Science or equivalent technical subject area is required
Minimum 4 years of related work experience
Experience in Quality Assurance/ Quality Systems
Knowledge of cGMP regulations and FDA/EU guidance
Strong written and verbal communication skills in English
Strong collaboration and time management skills
Ability to work in and support a global environment

Nice To Haves

Experience in a highly paced manufacturing environment is preferred

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.
Other duties can be assigned to support business continuity.

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
Consolidated retirement plan (pension)
Savings plan (401(k))