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
Bridgewater, NJ.
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
global customers.
- 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
completions.
- 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.
Qualifications- 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
preferred.
- 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
Bridgewater, NJ.
Primary LocationUnited States-New Jersey-Skillman
Other LocationsNorth America-United States-New Jersey-Raritan, North America-United States-New Jersey-Bridgewater
OrganizationJohnson & Johnson Services Inc. (6090)
Job FunctionQuality Systems