Senior Documentation Coordinator

Job description

Johnson & Johnson Vision (JJV), a member of Johnson & Johnson's Family of Companies is recruiting for Sr. Documentation Coordinator, to be located in Jacksonville, Florida.

JJV, is a worldwide company with operations in the United States, Japan, Latin America, Asia-Pacific and Europe/Middle East/Africa regions. Research, innovation and new-product development are the focus of our organization. Since we introduced soft disposable contact lenses in 1988, and through the acquisition of Abbott Medical Optics in 2017, no other manufacturer has matched the aggressive expansion of our wide-ranging Surgical Vision (Cataracts and Lasik portfolio) and Vision Care (ACUVUE and Consumer Eye Health solutions) family of products. Our associates around the world are committed to expanding the JV brand, and fortifying our position as the worldwide leader in total eye healthcare solutions.

Caring for the world, one person at a time has inspired and united the people of Johnson & Johnson for over 125 years. We embrace research and science -- bringing innovative ideas, products and services to advance the health and well-being of people. Employees of the Johnson & Johnson Family of Companies work with partners in health care to touch the lives of over a billion people every day, throughout the world.

The Senior Documentation Coordinator prepares submissions of SOPs for the document control process controlled through eDMS (QUMAS), ensuring compliance to ISO, GMP and BSI regulations, utilizing the computer networks to prepare documents to the on-line system. Responsible for maintaining and supporting departmental internal database maintenance of on-line indices. Lead responsibilities for document lifecycle management and process audits for the department. Researches, recommends and implements efficiency improving tools and procedures and takes action/responsibility for developing databases, reports, etc.

Evaluates Workflow Coordinator processes and communicates non-conformances to management.

Provides electronic storage for records retention to create images of documents and records for global documentation. Indexes and organizes records based on standardized cross-filing system which can be retrieved in a timely manner. Monitors records retention of documents related to the process and generates reports by retrieving records from electronic storage as requested. May perform other document-related duties outside the department such as document coordination, customer issue investigation, safety training/inspections, and internal audit support activities.

Promotes a culture of Regulatory Compliance and Risk Management throughout the organization. Supports departmental and franchise objectives, while adhering to the Johnson and Johnson Credo, as well as local safety and environmental policy and procedures.

Additional responsibilities include:

· Edits and prepares new/revised documents and forms that are submitted for the documentation processes, ensuring their compliance to ISO, GMP and BSI regulations.
· Utilizes computer networks to transfer approved (and effective) documents to the on-line system; maintains and supports on-line indices, organization charts, and signatory matrices.
· Performs scanning for required records created and maintained in the Global 360 application, creating computer image of specific documentation and stores the information electronically.
· Design and maintenance of databases including software upgrades and database configuration.
· Performs regular audits of documents in approval cycles.
· Evaluates Workflow Coordinator processes and communicates non-conformances to management and affected departments.
· Performs eDMS (QUMAS) training to company-wide individuals.
· Identifies group productivity/communication barriers and proposes solutions.
· Performs duties related to eDMS (QUMAS) Administrator and serves as Ireland & Japan point of contact for system troubleshooting.

Desired profile

Qualifications :

·  A minimum of a High School Diploma or equivalent is required and a college degree is preferred.
·  A minimum of two (2) years equivalent experience is required.
·  A minimum of five (5) or more year's previous clerical/technical experience in document management is preferred.
·  Must have thorough knowledge and understanding of administrative principles and concepts is required.
·  Working knowledge of QUMAS (eDocCompliance) is required.
·  Ability to utilize the Global360 database system for retrieving archived documents that are not listed within QUMAS is preferred.
·  Ability to use computer systems for off-site document storage activities is preferred.
·  Proven self-starting/high initiative track record is required.
·  Ability to work in a team setting is required.
·  Knowledge of ISO/GMP/BSI regulations is preferred.
·  Strong, proven organizational skills with the ability to work in a cross function environment is required.
·  Excellent communication skills (both verbal and written).

·  Ability to be flexible and manage multiple priorities successfully while working under pressure is required.
·  Expertise in company document management computerized system (QUMAS) both administrative side eDocCompliance is preferred.
·  Internal Auditing is preferred.
·  This position will be located in Jacksonville, FL.