Job Description

Senior Electronic Documentation Specialist
Job Number: 21-09340
 
Be part of a company that delivers life-changing healthcare solutions. Eclaro is looking for a Senior Electronic Documentation Specialist for our client in Summit, NJ
 
Eclaro’s client is a leader in the Biopharmaceutical Industry, providing quality, innovative, and affordable medicines that make a difference in the lives of patients all over the world. If you’re up to the challenge, then take a chance at this rewarding opportunity!
 
Position Overview:
  • The Senior Specialist is responsible for day-to-day QA Document Control operations at the Summit, NJ site, in accordance with Cell Therapy Development & Operations (CTDO) policies, standards, procedures and global cGMPs.
  • The position executes Document Control activities including but not limited to: Records Management System (RMS) administration; RMS training for new/current users; issuance, review and maintenance of controlled documents (including analytical forms, logbooks, drug product batch records and clinical drug product labeling); Periodic Review of quality documentation; support to other functional areas of operations; and review and approval of site specific procedures.
  • This position reports to the Manager of S12 Documentation Control.
 
Qualifications:
  • 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
  • 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
 
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 Client 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
 
If hired, you will enjoy the following Eclaro Benefits:
  • 401k Retirement Savings Plan administered by Merrill Lynch
  • Commuter Check Pretax Commuter Benefits
  • Eligibility to purchase Medical, Dental & Vision Insurance through Eclaro
 
If interested, you may contact:
Paul Quibuyen
Christian.Quibuyen@eclaro.com
6466952942
Paul Quibuyen | LinkedIn
 
Equal Opportunity Employer:
Eclaro values diversity and does not discriminate based on Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.

Application Instructions

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