Senior Specialist Documentation Control

Cardinal Health is partnering with a Global leader in Specialty Medicine, to launch a new drug into the US market. In building this organization, we’re looking for exceptional talent.


What Quality System Management contributes to Cardinal Health
Quality Systems Management is responsible for the development, deployment and maintenance of controlled documentation and supporting systems.

  • Demonstrates knowledge of quality systems.
  • Demonstrates a thorough understanding of the relevant regulations, standards and operating procedures.
  • Demonstrates an understanding of quality concepts such as: documentation systems, change control and electronic records.
  • Works well cross-functionally and has the ability to interpret the requirements as well as educate and influence others on those requirements.

Accountabilities in this role

  • Responsible for ensuring the accuracy and timeliness of controlled documents used as part of the production process.
  • Responsible for management of GMP document library & all associated technology transfer information from key business partners
  • Responsible for GMP review and approval process
  • Responsible for issuance and control of Master Batch Records, Laboratory Worksheets and other controlled documents.
  • Maintains controlled documents through electronic document management systems
  • Performs other duties as assigned

Qualifications:

  • Bachelor’s in related field, or equivalent work experience, preferred
  • Prior experience with technical writing, either SOP’s, or documenting processes
  • 3-5 years of relevant work experience in GMP and/or FDA regulated industry (Pharmaceutical or Medical Device)  
  • Must work well with others and understand how to be successful in a Team environment. 
  • Must be detail oriented, organized, able to multi-task, a self-starter, and self-motivated
  • Must be proficient in Microsoft Word and Microsoft Excel and possess strong technical writing skills
  • Must be proficient Electronic Data Management and SharePoint