Job Details

  • Title: Electronic Documentation Specialist
  • Code: RCI-39315-1
  • Location: Summit New Jersey (NJ) 07901
  • Posted Date: 06/22/2021
  • Duration: 6 Months
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  Job Description

Knowledge, Skills, and Abilities:
• Leads communication regarding potential issues to others in department. Coaches employees to bridge knowledge gap;
• Possesses strong authorship; able to write and critically review reports. Provides guidance to others in technical writing and in interpretation of complex data;
• Fosters a team culture dedicated to enhancing customer satisfaction and building business partner relationships;
• Must be action Orientated with an independent mindset;
• Possesses conflict management techniques/ideas designed to reduce the negative effects of conflict and enhance the positive outcomes for all parties involved.
• Demonstrates ability to plan/organize and allocate resources;
• Must have GMP, Quality and risk management knowledge
• Effectively prepares and conveys data analysis to management and others within group with clarity and accuracy;
• Possesses broadening technical knowledge and is able to analyze complete data in areas specific to job function at intermediate level;
• Contributes to the design and implementation of quality electronic documentation systems and practices;
• Demonstrates proficiency with PC-based office computers and standard Microsoft Office applications;
• Demonstrates ability to maintain current knowledge of applicable regulations and other regulatory changes.

Education and Experience:
• Relevant college or university degree preferred.
• Minimum 5 years of relevant industry experience, of which 2+ years of Document Control experience, is required.
• Experience with Veeva systems is preferred.
• Equivalent combination of education and experience acceptable.
• Previous experience in a gene or cell therapy facility is preferred (CAR T a plus).
• An equivalent combination of education and experience may substitute.

DUTIES AND RESPONSIBILITIES:
• Completes more complex tasks with moderate direction;
• Completes routine tasks with no supervision;
• Work is self-directed;
• Executes non-routine decisions in their subject matter area;
• Participates in cross-functional teams, as subject matter expert for electronic documentation systems.;
• Consulting supervisor for direction on managing personnel issues;
• Ability to fully interpret complex results and situations and articulate recommendations for resolution.
• Recognizes risk and develops contingency plans;
• Understands continuous improvement and improves efficiency and productivity within the group or project;
• Provides input within the function and cross-functional teams;
• Leverages relationships internally within function and with cross-functional teams and supports cross-functional objectives.
• Manages conflict issues with internal customers and able to recognize conflict and notify management with proposed recommendation for resolution;
• Show basic negotiation skills within work group and team;
• Demonstrates coaching skills and assists manager in ensuring staff are properly trained on controlled, approved GMP and Document Control procedures;
• Relays shift communication to Document Control team;
• Escalates concerns/ issues to Document Control Management;
• Document Administrator for the global electronic GMP/GDP documentation system in compliance with regulatory and BMS requirements;
• Contributes to effective documentation system KPIs, metrics, and proactive issue identification and resolution;
• Ensures that documentation complies with established electronic documentation system standards;
• Provides support during internal and health authority inspections of site facility;
• Executes documentation system-related Quality Systems Objectives as assigned;
• Serve as a Document Control Reviewer/Approver on documentation, managed through the electronic GMP/GDP documentation management system;
• Prints/Issues controlled documents, such as Master Batch Records and Batch Record Related documentation, logbooks, and analytical forms;
• Assists with maintenance and administration of procedures related to job function;
• Systematizes and streamlines document workflows;
• Provides end-user training on electronic document management systems;
• Supports Quality Systems harmonization efforts across the CTDO organization;
• Performs other tasks as assigned.