Johnson & Johnson Family of Companies is currently recruiting
for a Quality System Analyst II, Document Management at the preferred location
of Skillman, NJ, however considerations will also be made for Raritan, NJ and
Caring for the world, one person at a time, has inspired and
united the people of Johnson & Johnson for 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 Quality System Analyst II, Document Management will:
- Coordinate document management activities to support local and
- Be responsible for the following daily documentation related
activities: creation/edit, review, approval, effectuation, obsolescence,
archival and distribution.
- Coordinate the review and approval of GxP documents in the
electronic document management system.
- Provide expertise to document originators, ensuring documents are
created/edited per current procedures (i.e. correct template, format, content
references, document properties, types of approvers).
- Monitor, reconcile and audit approved documents, ensuring all
compliance requirements for format, content, standardization and periodic review.
- Ensure that customer expectations are met for the quality of the
final GxP document and its implementation schedule.
- Liaise with training department to ensure document effective date
does not result in adverse impact to trainees or training metrics.
- Provide oversight/support of periodic document review process, and
will run Periodic Document Review Cognos reports for Virtual Organizations and
send notifications to group owners and document authors to drive timely
- Assist with reporting and analysis of biannual JSC Global Periodic
Document Review metrics.
- Serve as an electronic document management system (EDMS) super
user and train new associates or document owners in document management
processes and the related EDMS.
- A combination of one of the following is required: Bachelor’s
degree plus 2 years of relevant experience; Associate’s degree plus 4 years of relevant
experience; High school diploma plus 6 years of relevant experience.
- A minimum of 2 years of related experience including Quality
Assurance, Quality Systems and/or Quality Control in the pharmaceutical/OTC or
other highly regulated industry is required.
- A minimum of 2 years’ experience in document management which
includes use of an electronic document management system is required.
- Knowledge of FDA/EMEA regulations and 21 CFR Part 11 requirements
as well as cGMP related to documentation required.
- Prior experience delivering training to colleagues and partners is
- Experience providing support for internal audits and inspections
by regulatory authorities is a plus.
- This position will be located in Skillman, NJ, Raritan, NJ, or
United States-New Jersey-SkillmanOther Locations
North America-United States-New Jersey-Raritan, North America-United States-New Jersey-BridgewaterOrganization
Johnson & Johnson Services Inc. (6090)Job Function
A little about us:
Johnson & Johnson cares for the world - bringing innovative ideas, products and services to advance the health and well-being of people.