Senior Document Specialist - NY

Company: Curia
Location: Decatur
Posted on: March 20, 2023

Job Description:

SENIOR DOCUMENT SPECIALIST in Rensselaer, NY

The Senior Document Specialist is responsible for overseeing the archiving, retention, and destruction of archived documents for the site and for properly maintaining documents and systems required by Good Manufacturing Practices (GMPs). The position also becomes actively involved, as needed, to meet schedules and resolve problems associated with the document archive process and frequently interacts with functional peer groups at various levels. This role is responsible for formatting, obtaining approvals, mastering and distributing standard operating procedures (SOPs), forms, batch records, protocols, logbooks, project notebooks and material specifications. Critical thinking, attention to detail, and excellent written and verbal communication skills are essential to the position.

Essential job duties

• Serve as in-house expert for all controlled documents, as well as file processing and management, document version control, and dissemination
  
• Organize, administer, and oversee the maintenance of an electronic and hard-copy organizational structure for effective storage and retrieval of all documents
  
• Provide document control instruction to company employees by training personnel in formatting SOPs, using Word and in Controlled Document Management System
  
• Manage external requests for documents, including reviewing and proofing the documents
  
• Provide support for development and maintenance of Logbook Database, Product Code Master List and Controlled Document List database and create logbooks when appropriate
  
• Serve as an in-house expert on the creation and closure of change controls specifically related to controlled documents
  
• Prepare, archive, track, retrieve, store, and disposition all documents sent to the archives from various departments
  
• Interact with supervisors, other peers, other departments, and outside customers to identify, address and resolve problems in a timely manner; manage time and workload with limited or no supervision, as well as seek assistance as required
  
• Issue master batch records for the manufacturing process
  
• Maintain accurate electronic and hardcopy document files and database records
  
• Act as scribe in the event of regulatory audits
  
• Oversee and administer SOP mandatory review process
  
• Develop and/or maintain Quality System metrics for management review
  
• Assist with the preparation of Annual Product Reviews
  
• Scan executed batch records to the customer portal
  
• Assist in performing investigations and executing CAPA plans
  
• Track and process change controls through closure
  
  Education, experience, certification and licensures
  
  Required
  
• Associate's degree in relevant field
  
• 3-5 years' direct experience in a GMP environment
  Preferred
  
  • Bachelor's degree in relevant field
    
  • Aseptic technique/manufacturing experience
    
  • Knowledge and understanding of specific systems such as MasterControl, TrackWise, and ERP
    
  • Familiar with normal cGMP terminology
    
  • In-depth knowledge of the Change Control process
    
    Curia is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability.
    
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Keywords: Curia, Decatur , Senior Document Specialist - NY, Other , Decatur, Illinois