Document Control\/Training Specialist
Pharmaron

Job Info

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Come Join Our Growing Team!

The Document Control/Training Supervisor will manage document workflows through respective document life cycle, issue maintain employee training records utilizing TrackWise Digital - Learning Management System (LMS), coordinate, and provide GLP training to Pharmaron employees as needed.

Essential Functions

• Maintain a document management system and learning management system compliant with regulatory, quality, and Pharmaron requirements
• Ensure completion of improvement projects to enable process efficiencies in document security/archival
• Manage the archive system for all document at the site.
• Routine interface with TrackWise for document control coordination purposes.
• Collaborate with cross-functional departments to ensure timely implementation of changes to control process
• Provide training and troubleshooting assistance for users regarding Electronic Document Management System (EDMS).
• Oversee GLP New Hire Orientation and Onboarding Training Program for all employees and contractors/consultants.
• Work closely with site teams to develop a robust training program to ensure employees are qualified to perform duties
• Conduct training on applicable site procedures and that training files are maintained
• Act as the system administration for Pharmaron's EDMS
• Ensure escalation of significant compliance events to Director, QA
• Manage hardcopy records, scans, and database entries for all archived GLP records.
• Support archival of GXP (GCP and GLP) documents including use and management of associated electronic systems and databases.
• Monitor document control inventory supply and place requisitions
• Support client and regulatory audits.

Required Education and Experience

• Bachelor's Degree in Biology, Chemistry or related field is required
  
• 2-3 years of QA experience related industry experience
  
• Knowledge of FDA regulations, 21 CFR Part 11, 58 and ICH Quality Guidelines.
  
• Knowledge of Good Laboratory Practices (GLP) - a quality system of management controls for research laboratories and organizations to ensure the uniformity, consistency, reliability, reproducibility, quality, and integrity of chemical (including pharmaceuticals) non-clinical safety tests; from physio-chemical properties through acute to chronic toxicity tests.
  

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