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Document Control Specialist

2 months ago

Fort Dodge, Iowa, United States Elanco Animal Health Incorporated Full time
About Elanco Animal Health Incorporated

At Elanco Animal Health Incorporated, we are dedicated to innovation and delivering products and services to prevent and treat disease in farm animals and pets. Our vision is to advance the health of animals, people, the planet, and our enterprise.

About the Role

The Document Control Specialist - Quality Assurance will support the site's overall document control system. This role will be responsible for preparing, reviewing, and issuing batch records, ensuring compliance to Good Documentation Practices, regulations, and company SOPs.

Key Responsibilities
  • Document Control: Manage document control systems, train staff on good documentation practices, and maintain document traceability and retrieval.
  • Batch Record Management: Prepare, review, and issue batch records according to schedule, ensuring compliance to Good Documentation Practices, regulations, and company SOPs.
  • Quality Assurance: Implement batch record holds per deviation impact assessments, initiate deviations in quality systems for non-conformances, and ensure timely QA approvals.
  • Project Participation: Actively participate in and lead projects, contributing to idea generation, solution development, and process improvement.
  • Regulatory Compliance: Participate in internal audits, prepare for regulatory agency audits and customer inspections, and provide support during inspections.
Requirements
  • Education: High School Diploma/GED
  • Attention to Detail: Strong attention to detail with a quality assurance mindset.
  • Communication Skills: Good written communication skills, including attention to detail, ability to follow written procedures, SOPs, specifications, and other documents.
  • Mathematical Skills: Ability to perform basic mathematical calculations.
Preferred Qualifications
  • Additional Education: Additional education (Bachelors or Associates degree)