Analyst II- Document Specialist

rockville, Maryland
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Type: Contract

Category: Scientific & Clinical

Job ID: 137029

Date Posted: 02/11/2019


 

Job Title:  Documentation Specialist-Analyst II
Location: Rockville, MD 

A leading biotech company in Rockville, MD is seeking a Document Specialist. For immediate consideration please email your resume to Senior Recruiter Ivy Fairfax at ifairfax@jouleinc.com. 


Job Description

 

  • Provide oversight and support of documentation and records management for the site using company procedures and regulations.  
  • Ensure CAPAs and CCs are addressed and closed timely relating to manufacturing, technical operations and quality control for the Fill and Finish Facility.
  • Support efforts for continuous improvement in deviation and CAPA reduction as well as manufacturing operations for the site.  
  • Support completion of department operational tasks related to record and document revision, creation, processing.
  • Work closely with various departments to understand requirements for documentation revisions.
  • Create new SOPs, forms, protocols, reports and edit existing documents as necessary. Format the current documents to the company required format utilizing Microsoft Word and the Veeva system.    
  • Independently gather information from subject matter experts to develop, organize, and revise SOPs and other documents.
  • Review and compile documentation to assist with deviation investigations. Complete and close CAPA and CC effectiveness checks.
  • Complete CAPA and CC deliverables and close associated tasks utilizing the SAP system
  • Author and execute tasks for document revisions, deviations, CAPAs, and change controls related to all departments.
  • Compile and report performance metrics for quality systems. Participate on response teams to address observations and recommendations made during inspections.
  • Identify opportunities for improvement within scope of work.

Job Requirements

  • BS degree or equivalent level of skill and experience.
  • 2-4 years of experience with electronic document management (Veeva experience preferred), deviation, CAPA, and change control systems (SAP experience preferred) in a GMP, FDA regulated environment
  • Microsoft Office Specialist certification, Records management experience, Configuration management experience preferred


 


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