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Laboratory Data Systems Engineer

Company: Akorn, Inc
Location: Decatur
Posted on: May 11, 2019

Job Description:

SUMMARYProvides technical support for all data systems used by of Akron Incorporated Quality Control (Chemistry and Microbiology) Laboratories. ESSENTIAL FUNCTIONS:This position is responsible for handling all administrative activities associated with laboratory equipment and computerized systems, including but not limited to HPLC, GC, UV-Visible Spectrophotometer, IR Spectrometer, Karl Fischer Autotitrator, Viscometer, HIAC, Vitek etc. The laboratory system administrator is responsible to assure compliance of laboratory computerized systems to Akorn policies and regulatory standards. The laboratory system administrator is responsible for working collaboratively with system end-users and business process owners to review systems, work-flows and assess risks of process/equipment and aid in the development and execution of associated validation activities. The lab administrator is responsible to work with cross functional teams to perform periodic assessments of laboratory systems and associated supplemental actions to maintain compliance of laboratory systems. Prioritizes assignments to fulfill all Company needs. Assists staff with the troubleshooting of analytical methods/instruments. Administrator for all software types utilized by the Quality Control, Microbiology and Analytical technical services laboratories. Enforces all company compliance and safety requirements. Initiates/Conducts/Completes laboratory investigations following written guidelines in a scientific and expeditious fashion. ADDITIONAL RESPONSIBILITIES:

  • Serve as the computer system application specialist for all laboratory data systems
  • Participating in the authorship, execution and review of GAMP5 computer system validation of laboratory systems
  • Participate in the development, and execution of computerized data migration and verification protocols
  • Prioritize periodic validation assessments of laboratory systems to assure integrity of laboratory data generated within the systems.
  • Perform routine queries and system audit trail reviews of all computerized systems within
  • Responsible for inventory management of laboratory data systems
  • Responsible for initiating and executing change control within laboratory data systems.
  • Coordination with vendors as appropriate to troubleshoot and resolve application issues within the laboratory data systems.
  • Creates/revises standard operating procedures when required including the review and administration of associated lab data systems.
  • Actively participate in implementation of new laboratory equipment and laboratory modernization and compliance initiatives.
  • Report risks observed during periodic review of systems through system analysis report with risk documentation
  • Communicates effectively with all interdepartmental/intradepartmental personnel. Proactively communicates any problems or delays to all necessary individuals.
  • Ensures all Events or CAPA (Corrective Action/Preventive Action) items are completed expeditiously and before the completion date.--

Keywords: Akorn, Inc, Decatur , Laboratory Data Systems Engineer, Other , Decatur, Illinois

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