Title Lab Software Administrator
Job Summary

We are seeking a Lab Software Administrator to join our Analytical R&D team at our Philadelphia location. The Lab software administrator will be responsible for administering lab GMP computer systems used in Analytical R&D lab and help to validate computer system and software. The Lab software administrator will be work with management to upgrade current computer systems and software, to acquire new computer systems and software to keep the Analytical R&D lab up to the current GMP and business requirements. Time permitting, also support other departments, such as QC lab and Compliance department on computer system and software validation and administering.


Essential Functions

  • Create and maintain user accounts for Empower, Stability System II, Malvern Mastersizer 3000, and software for other stand-alone instruments;
  • Administering Empower servers, LAC/E boxes, and other computers for stand-alone instruments;
  • Resolve software and instrument computer related issues to support analytical testing in a timely manner;
  • Perform data-integrity review for all the lab computers and software per compliance requirements and company SOPs;
  • Create and validate custom fields and reports per the company needs;
  • Work with IT Department on data backup and archiving;
  • Work with Compliance Department on software and computer validation;
  • Lead and coordinator computer/software upgrade and acquisition / installation / qualification/validation of new software and computers for instruments;
  • Write/Review/Approve related SOPs;
  • Review analytical test data per company needs;
  • Help to manage lab documents in MasterControl system;
  • Other duties as assigned.
  • MS or BS in Chemistry, Computer, or other related scientific fields with 2+ years of related experience;
  • Experience with Waters Empower is a must;
  • Experience with Computer System Validation following GAMP desired;
  • Knowledge of cGMP and FDA regulations;
  • Excellent written and oral communication skills and interpersonal skills.
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