Senior Specialist, Quality Systems

Janssen Pharmaceuticals, Inc., a member of Johnson & Johnson's Family of Companies, is recruiting for Sr Specialist, 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.

Learn more at https://www.jnj.com/.

Are you interested in joining a team that is positively impacting patients' lives by ensuring high quality in our cell therapy products? Apply today for this exciting opportunity!

The Sr Specialist, Quality Systems will independently perform Quality Systems activities, identify issues, and implement resolutions, assess data, and independently prepare and review documentation.
Key Responsibilities:


* Provide support and robust guidance for Quality Systems, including document management and metrics reporting.


* Ensure compliance to the Quality Systems procedures and policies.


* Actively participate in global super user network meetings and communicate relevant information to the team/site.


* Review wide variety of documents for compliance to procedures, including SOPs, Work Instructions, Technical Documents, Logbooks, Forms.


* Drive alignment and efficiencies between global and local processes.


* Provide quality input on quality systems related issues and represent department in meetings.


* Coordinate and conduct Quality Systems Review meetings.


* Support internal and external audits, inspections, pre-inspection readiness, certifications, tracking, and trending activities.


* Work closely with management and various team members to propose and complete improvements activities.


* Ability to respond swiftly to departmental and interdepartmental requests.


* Perform tasks in a manner consistent with the safety policies, quality systems, and cGMP requirements.


* Other duties will be assigned, as needed.

Education:


* Minimum of a Bachelor's degree is required with a focus in Biology, Engineering, Science, or equivalent technical subject area is preferred.

Experience and Skills:

Required:


* A minimum of four (4) years of experience in Quality Systems, Quality Assurance, Quality Control, Validation or Engineering in pharmaceutical industry, across various roles.


* Strong communication (verbal, written, and presentation) and interpersonal skills, self-awareness, and adaptability.


* Ability to work on complex issues with minimal direction and think analytically.

Preferred:


* Familiarity with Quality Event Management systems (Trackwise, COMET, or equivalent systems).
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