Quality Assurance Documentation Specialist - Johnson & Johnson : Job Details

Johnson & Johnson is currently seeking a Quality Assurance Documentation Specialist to join our Johnson & Johnson Innovative Medicine Supply Chain organization located in Wilson, North Carolina.

While this role will ultimately support the site operations located in Wilson NC, this role will also be required to support the project phase across both design & construction. For the project design phase, the role will require you to be present with our design teams in the Greater Philadelphia region. Once the design phase is completed, this role will support the construction and operational start-up of the site. For this, you will be required to be on site in Wilson, NC. Based on your current location the hiring team will work with you to determine travel and relocation arrangements. In steady state, we expect travel to be less than 10%.

J&J is expanding our manufacturing capacity with $2 billion investment to support strong?portfolio growth and continue delivering breakthrough innovation and transformational medicines?for patients. The new facility will expand production of innovative biologic medicines in areas including oncology, immunology, and neuroscience. J&J's significant supply chain investment ensures a resilient and reliable future supply of medicines to meet accelerating demand for our current portfolio of medicines and our future innovations.

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

For more than 130 years, diversity, equity & inclusion (DEI) has been a part of our cultural fabric at Johnson & Johnson and woven into how we do business every day. Rooted in Our Credo, the values of DEI fuel our pursuit to create a healthier, more equitable world. Our diverse workforce and culture of belonging accelerate innovation to solve the world's most pressing healthcare challenges.

We know that the success of our business - and our ability to deliver meaningful solutions - depends on how well we understand and meet the diverse needs of the communities we serve. Which is why we foster a culture of inclusion and belonging where all perspectives, abilities and experiences are valued and our people can reach their potential.

At Johnson & Johnson, we all belong.

We are currently seeking a highly qualified individual to join our QC team as a Quality Assurance Documentation Specialist at our new Large Molecule Drug Substance Manufacturing facility. In this key role, you will be responsible for carrying out tasks and projects related to document control including administration of the Electronic Document Management System (EDMS), preparation/submission of documents into and retrieval from archive, and the management of controlled documents through the review, approval, circulation and revision processes.

Essential Job Duties and Responsibilities:

* Provides support and direction to all departments in respect of Quality Documentation Systems to ensure business, quality and compliance goals are met.

* Partners with other departments to ensure that Documentation programs and Records Management policies are completed in a compliant and efficient manner.

* Supports the development and management of GMP compliance systems.

* Carries out tasks related to the management of Document Control and Records Management in respect GMP regulated documents and records.

* Develops and applies systems and procedures related to the EDMS at the site.

* Develops and implements processes, procedures and tools related to the implementation of compliance systems at the site.

* Coordinates the Records Management Policy for the site.

* Provides training in Good Documentation Practice (GDP) and GMP to site personnel as directed as directed by the Quality Systems Team Lead.

* Develops and maintains training materials for provision of GDP and GMP training to site personnel.

* Supports Inspection readiness at the site as documentation and Records Management SME.