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Technical Author Saint Louis, MO   
     
Posted:  1/11/2019
 
Job Description

Alphanumeric is hiring a TECHNICAL AUTHOR to work in St. Louis, MO with one of the largest pharmaceutical companies in the world.
 
Key Responsibilities:
 
  • Ensure quality and compliance in accordance with established procedures and standards of the Quality System.
  • Comply with and support the  Environmental, Health and Safety policies and procedures. 
  • Create User Requirement Specifications in accordance with Site SOP’s and cGMP’s. 
  • Create and Update of Standard Operation Procedures in consultation with Subject Matter Experts 
  • Create and update batch records and department forms 
  • Stream-line batch documentation and Standard Operation Procedures within the Manufacturing department using lean methodologies. 
  • Participate in Root Cause Analysis and creation of Corrective and Preventative Actions, particularly as it relates to batch documentation and SOP’s.
  • Comply with all operational safety, process safety, environmental permits, Quality policies, procedures and training requirements. 
 


Job Requirements

Key Skills/Education/Experience:
 
  • 2 years related experience with High School Diploma or 0 years with Bachelor’s Degree 
  • Competent in use of templates and forms 
  • Strong skills in Microsoft Excel, Microsoft Office, and Powerpoint 
  • Good understanding of GMP documentation practices 
  • Ability to understand technical processes and communicate those to others 
  • Ability to train/coach others without use of authority 
  • Strong command of the English language, including proper use of spelling, grammar, and typical technical writing standards.




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