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Analytical Support Specialist Rockville, MD   
     
Posted:  12/4/2018
 
Job Description

Alphanumeric is hiring an Analytical Support Specialist to work in Rockville, MD with one of the largest pharmaceutical companies in the world.
 
Responsibilities:
  • Serve as system administrator on laboratory systems to identify, analyze, and troubleshoot problems. 
  • Assist with development of system administration process 
  • Deliver user, process, and technical specifications and design documents. 
  • Assess laboratory systems for regulatory compliance requirements. 
  • Implement solutions to ensure laboratory systems compliance 
  • Develop and report key usage and performance metrics for systems. 
  • Provide user training and support. 
  • Manage efforts throughout the lifecycle of laboratory equipment. From planning thru decommissioning. 
  • Assist with development of laboratory system lifecycle management process
  • Author, revise, and review SOPs as necessary. 


Job Requirements

Skills/Education/Experience: 
  • BS degree in scientific discipline 
    Area of Specialization* Laboratory system experience and general GMP 
  • Preferred Level of Education BS/ MS 
    Area of Specialization Laboratory system and Computer Science 
  • 3-5 years of experience managing information systems in a GxP regulated environment 
  • Strong interpersonal and leadership skills.
  • Solid team player able to function within a team-based organization. 
  • Strong verbal and written communication skills. 
  • Able to interact with peers and senior personnel in a multidisciplinary environment including validation, production and IT 
  • Ability to prioritize and decide appropriate course of actions. Effective at implementing decisions and multi-tasking. 
  • Fully versed in GMP’s, NIH, ICH Guidelines, FDA and other regulatory agency requirements for validation and operations of analytical and stability functions.




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