Document Management/Compliance and Training Specialist (JM)

Document Management/Compliance and Training Specialist

Client: Tibotec Therapeutics (A Johnson & Johnson Company)
Location: Bridgewater, NJ 08807
Industry: Pharmaceutical
Interview Schedule: Phone screen, then personal interview with hiring manager and technical team leaders.

Job Description:
Document Management Quality / IT Systems
• Change request management
• Document Upload and Routing for Review and Approval
• Management of 'official' documents and distribution to external service providers
• Glossary Management
• Manage Tibotec Procedural Deviations
• Administer and Distribute Tibotec Management Reporting for Training Compliance
• Records Retention / Archival Support
Regulatory Compliance Consultancy
Health Authority Inspection Support (FDA, MHRA) and J&J Internal Audit Support
• Pre Audit / Inspection Training and SME Identification
• Pre Audit Review of Relevant Documentation
• Facilitation of Audit / Inspection Process
• Coordination of Audit / Inspection CAPA and Communication
CAPA Management and Tracking
Document Support
• Maintain CVs/JDs electronically in ODIN/Gemini or other location
• Maintain training records in eUniversity and/or ComplianceWire and paper if needed
• Maintain training plan

LMS and training administration (eUniversity and/or ComplianceWire)
• Manage user accounts (internal)
• Manage user accounts (vendor)
• Provide technical support through our support email
• Add courses into the LMS
• Make training assignments
• Create and maintain role-based curricula
• Track completions of training and provide reports to appropriate personnel
• Run audit reports and gather associated records
SOP Training
• Create SOP training materials and assessments (OMJSA Lectora and Pedagogue or other tools, e.g., ComplianceWire)

Vendor Training
• Provide vendor training and curricula for AE/PQC and associated SOPs through eUniversity.


Notes from Hiring Manager:
• Looking for someone with a document management, compliance and training background.
• Looking for someone with technical writing experience, preferably procedural writing
• They will be developing compliance training questions/content and then testing it and rolling it out to the LMS system.
• CAPA experience - they will be evaluating and providing feedback on CAPA. Working with stakeholders and tracking closure.
• Looking for someone with a medical device or pharmaceutical background
• They prefer a BS degree, but not required
• Plus experience: ComplianceWire and SumTotal (both LMS systems)
• Plus experience: Lectora (very niche) and Pedagogue
• Plus experience: project management
• Plus experience: Trackwise
• Plus experience: any Documentum based systems


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If you have received this job description and are not interested, please forward the description and my contact information onto your network of contacts and friends.  A lot of candidates learn of new job opportunities from word-of-mouth, and any referrals would be greatly appreciated.  Our job opportunities are usually time sensitive, so please contact me immediately if interested.  Thank you.

Category:	Biotech/Pharmaceutical
	> Regulatory Affairs      > Document Control      > Other Biotechnology      > Other Pharmaceutical
Location:	Bridgewater, NJ
County:	Somerset County
ZIP Code:	08807
Pay Rate:	Open
Job Terms:	over 1 year (contract)
Company:	APEX Systems, Inc.
Phone:	email only
Fax:	email only