Quality Document Control Specialist

Om jobbet

The Document Control Specialist is responsible for ensuring that all Standard Operating Procedures are up to date, and uploaded into Master Control. The Document Control Specialist may also assist with revising SOPs and working with internal stakeholders to communicate changes in SOPs to affected departments.

Role Responsibilities:

  • Manage Document Change Requests in MasterControl
  • Manage documentation from FSS east and FSS west, with ultimate goal to harmonized data into one system
  • Work with each department to assist with document collaborations
  • Review/Revise current Document Control Procedure as Fagron Sterile Services
  • Report late or expire documents to appropriate departments or individuals
  • Understand Change Control Process.

Din profil

Profile/Experiences:

  • Bachelor’s Degree in a Science related field and 2-3 years of Pharmaceutical experience or an equivalent combined of education and experience
  • Experience with Digital Document Management Systems/MasterControl Trackwise, Documentum preferred
  • Experience reading and revising SOP, PBR, MBR, Job Aids and Training Modules
  • Experience with Writing Technical Documents/Procedures
  • Trained in cGMP and GMP
  • Working understanding of DEA regulations and 21 CFR 210 and 211
  • Ability to work interdepartmentally and communicate effectively with various departments
  • Excellent attention to detail
  • Ability to excel in in a fast pace environment
  • Excellent Organization Skills
  • Ability to prioritize tasks

 

Vi tilbyder

We offer a dynamic environment where talent and ambition can develop to its fullest. We have an open and informal organization culture, where individuals need to have strong motivation and ability to work independently. Fagron is a widely expanding, international, professional and ambitious pharmaceutical company with multiple growth opportunities. Job opportunity includes competitive salary, comprehensive benefits, performance package, and ability to be part of an international leader in an expanding industry.