Quality Systems Specialist

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 .

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.

Job Function:
Quality

Job Sub Function:
Quality Systems

Job Category:
Professional

All Job Posting Locations:
Wilson, North Carolina, United States of America

Job Description:

We are currently seeking a highly qualified individual to join our team as a Quality Systems Specialist at our new Biotherapeutics Manufacturing facility in Wilson, North Carolina (BioNC).

Our expertise in Innovative Medicine is informed and inspired by patients, whose insights fuel our science-based advancements.

Visionaries like you work on teams that save lives by developing the medicines of tomorrow.

Join us in developing treatments, finding cures, and pioneering the path from lab to life while championing patients every step of the way.

Learn more at https://www.jnj.com/innovative-medicine

Essential Job Duties and Responsibilities

This position is responsible for leading and/or supporting Quality Systems, which includes Document Management, Training, Deviations/CAPAs, Audits, Change controls, Gap Assessments, Specifications, Quality Agreements, Quality Management review and Annual Product Reviews within the scope of the organization.

Specific tasks and job duties required include, at minimum:


* Serves as a Quality Systems subject matter expert for the Wilson manufacturing site


* Facilitates and/or supports the Change Control Board, Change Control Review Board, and CAPA Review Board to ensure business, quality, and compliance goals are met


* Provides support and direction to all departments regarding specific quality system elements to ensure business, quality and compliance goals are met following the J&J Standards


* Provides support and direction to all departments in respect of document control to ensure business, quality and compliance goals are met


* Partners with other departments to ensure all Quality systems and associated programs are completed in an efficient and compliant manner


* Performs tasks related to the management of document control and records management in respect of SOPs and other GMP regulated documents
+ Receives and logs documents submitted by site personnel for inclusion into the documen...