Job Description

Senior Specialist, Document Control
Job Number: 21-13288
 
Be part of a company that delivers life-changing healthcare solutions. Eclaro is looking for a Senior Specialist, Document Control for our client in Devens, MA.
 
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:
  • Responsible for executing the initiation, processing, routing, distribution, and archiving of cGMP records.
  • The Senior Specialist, Document Control role is stationed in client’s site and reports to the Senior Manager of Document Control.
 
Responsibilities:
  • Executes the initiation, processing, routing, distribution and archiving of cGMP documentation and directs the compliance of documentation.
  • Provides direction on the document change control business process for to stakeholders and customers.
  • Ensures alignment of department procedures with global and site policies and procedures.
  • Serves as a subject matter expert for the electronic document management system to internal and external clients.
  • Assists in the development and review of Document Control-related procedures.
  • Conducts user training on the electronic document management system and assists with onboarding of new personnel in regards to Document Control-related systems and processes.
  • Provides direct Records Management support during regulatory agency inspections and corporate audits.
 
Qualifications:
  • Knowledge of science generally attained through studies resulting in a B.S., in science, engineering, biochemistry or related discipline, or its equivalent is preferred
  • A minimum of 4 years of relevant experience, direct document management experience in a regulated environment focused on product quality is preferred.
  • Strong teamwork, time management, organizational and communication skills and the ability to follow written and verbal instructions are required.
  • Knowledge of cell therapy, biologics manufacturing, or analytical testing is highly desirable.
  • Familiar with and able to interpret relevant regulations, regulatory agency inspection expectations (e.g. FDA, EMEA, Health Canada, etc.) is required.
  • Excellent computer skills and knowledge of MS Office and Document Management systems is required.
  • Direct experience with, and technical knowledge of the administration of an electronic document management system (EDMS) in a relevant industry.
  • Experience in providing guidance on compliance-related issues.
 
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
646-695-2942
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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