Document Control Analyst jobs in Paramus, NJ

Document Control Specialist
Allendale, NJ

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Skills : Gmp, fda, records.

Document Control Specialist

Overview:

The Document Control Specialist will be responsible for the management and maintenance of the electronic Document Management System (eDMS), consisting of document generation, control, and compliance of electronic generated documents. In this role the DCS is responsible for all Records Management activities; storage, retention and archival of original paper documents associated with Clinical Development, Technology Transfer and Clinical/Commercial Manufacturing. The DCS will support any client or regulatory inspections by providing the appropriate documentation based upon audit requests. The DCS will lead or co-lead cross-functional teams to coordinate and monitor Document Control and Records Management related activities. The DCS will also participate in various project teams or activities that align with the function’s strategic vision. The DCS will also be the primary backup for e-QMS System Administration and Coordinator responsibilities for other Quality Systems such as Change Control.

Essential Functions and Responsibilitie

Receipt of incoming record(s)
Document record(s) receipt in record location database
Prepare record(s) for repository storage location
File record(s) in assigned storage location
Monitor record request inbox
Respond to incoming record withdrawal requests
Prepare requested record for distribution
Notify requestor record is available for distribution
Document record withdrawal in record location database
Follow up/reconciliation of distributed record(s)
Receipt of incoming logbook(s)/notebook(s)
Document logbook(s)/notebook(s) receipt in record location database
Prepare logbook(s)/notebook(s) for repository storage location
File logbook(s)/notebook(s) in assigned storage location
Monitor logbook/notebook creation email requests
Respond to incoming logbook/notebook creation requests
Prepare requested logbook/notebook for distribution
Document logbook/notebook distribution in record location database
Notify requestor logbook/notebook is available for distribution
Follow up/reconciliation of distributed logbook(s)/notebook(s)
Record Management/Archival
Management of records retention program
Prepare/inventory documents, records, and logbooks/notebooks for internal and offsite archival
Support client closeout tasks related to documentation
Manage Tracking spreadsheets for inventory and archival(onsite/offsite)
Audit Support
Provide support of client and regulatory inspections by providing documentation in a timely fashion
DMS (Document Management System)
Train personnel for document authoring & reviewer/approver role within DMS
Perform administrator duties in DMS
Create/revise quality documents in DMS
Review documents in DMS for GDP compliance/template adherence
Manage publishing documents process in DMS to support business initiatives
Document and manage documentation metrics
Qualifications

Bachelor of Science in biological sciences or other relevant field of study
5 years Records Management knowledge/experience (preferably with GxP Documents, SOPs, Protocols, Batch Records, Validation Documents etc.)
Clinical/Research/Pharmaceutical experience a plus.
Technical writing experience within a scientific related environment a plus
Experience with e-DMS systems and e-QMS systems