Senior Analyst, Quality Systems

At Johnson & Johnson,we believe health is everything.

Our strength in healthcare innovation empowers us to build aworld where complex diseases are prevented, treated, and cured,where treatments are smarter and less invasive, andsolutions 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.Learn more at jnj.com

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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.

Job Function:
Quality

Job Sub Function:
Quality Systems

Job Category:
Professional

All Job Posting Locations:
Raritan, New Jersey, United States of America

Job Description:

Johnson & Johnson is currently recruiting for a Senior Analyst, Quality Systems.

This position will be located in Raritan, NJ.
Key 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.

Qualifications:
Education:

Minimum of a bachelor's degree in engineering, Science or equivalent technical subject area is required
Experience and Skills:

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

Preferred:

Experience in a highly paced manufacturing environment is preferred
Other:

Requires ability and flexibility to provide occasional support at off-shift hours.

Johnson & Johnson is an Equal Opport...