Our biotechnology client seeks a Document Control Specialist who 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.

• 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

REQUIREMENTS

• 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
• Relevant IT skills (Word and Excel) (Visio, Microsoft Project a plus)
• Time management, organization/prioritization skills
• Ability to multi-task in a fast-paced environment; deadline driven
• Strong written and oral communication skills
• Ability to think strategically (detail-oriented)
• Effective problem-solving skills
• Strong influencing skills and ability to work well in a cross-functional, matrixed environment is essential
• Sound Decision making skills
• Ability to effectively collaborate with peers and management

Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties, or responsibilities that are required of the employee for this job. Duties, responsibilities, and activities may change at any time with or without notice.

Lynkx Staffing LLC specializes in placing talented professionals in the Biotechnology, Pharmaceutical and Medical Devices industries in New Jersey.