Document Specialist

2 weeks ago


Portage, Indiana, United States Ursitti Enterprises LLC Full time

Job Title: Document Specialist at Leading Pharmaceutical Manufacturer

Company: Portage Facility


Job Description:
We are in search of a detail-oriented and meticulous Document Specialist to become part of our client's team in Portage.
As a Document Specialist, you will play a vital role in managing and organizing various crucial documents essential for their daily operations, including regulatory submissions, SOPs, clinical trial documents, and other key records.

Responsibilities:
  • Document Management: Ensure accurate and timely creation, revision, and maintenance of documents following established guidelines and regulatory requirements
  • Quality Control: Conduct thorough quality checks on documents to guarantee accuracy, consistency, and compliance with internal standards and regulations
  • Document Review: Review documents for completeness, accuracy, and clarity, collaborating with stakeholders to resolve discrepancies
  • Version Control: Efficiently manage document versions, maintaining a clear history for easy tracking and retrieval
  • Documentation Support: Aid various departments by preparing, formatting, and distributing documents as necessary
  • Training and Compliance: Support employee training on document management processes to ensure adherence to company policies and regulatory standards
  • Continuous Improvement: Identify opportunities for enhancing process efficiency within the document management system

Qualifications:
  • Bachelor's degree or equivalent experience in life sciences, business administration, or a related field
  • Prior experience in document management, particularly in pharmaceutical or healthcare sectors
  • Strong attention to detail and exceptional organizational skills, adept at managing multiple tasks and priorities
  • Proficiency in Microsoft Office Suite and document management software
  • Familiarity with regulatory requirements (e.g., FDA, EMA) and industry standards (e.g., GCP, GMP) is advantageous
  • Excellent communication and interpersonal skills, able to collaborate effectively with diverse teams


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