Senior Analyst, Quality Systems
About The Position
Johnson & Johnson is currently recruiting for a Senior Analyst, Quality Systems. This position will be located in Raritan, NJ. At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. As guided by Our Credo, Johnson & Johnson is responsible to our employees who work with us throughout the world. We provide an inclusive work environment where each person is considered as an individual. At Johnson & Johnson, we respect the diversity and dignity of our employees and recognize their merit.
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 period10 days
- Volunteer Leave – 32 hours per calendar year
- Military Spouse Time-Off – 80 hours per calendar year
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What This Job Offers
Job Type
Full-time
Career Level
Senior
