Lab Systems Administration

8/18/22

Riverview, MI

1798

1798 Lab Systems Administrator:

POSITION SUMMARY: The Laboratory Systems Administrator is responsible for the administration and coordination of laboratory system software to meet end-user needs and regulatory expectations (21 CFR Part 11 and cGMP), and established SOP’s.

Key responsibilities.

  • As an integral member of the Laboratory Information Management System (LIMS) implementation team, manage the deployment, set-up, configuration (creating workflows, analytical test methods, and analytical specifications), validation (IQ/OQ/PQ, validation plans, user requirements, risk assessments, using GAMP requirements), and execution of test scripts for the LIMS system.
  • Perform all duties as LIMS administrator, on-going configuration and improvements, develop custom reports, troubleshooting, and maintenance in conjunction with IT.
  • Administer analytical laboratory software systems, including the Chromatography Data System (CDS) for GC, GCMS, HPLC, and LCMS systems and Agilent Enterprise Content Manager (ECM) ensuring 21 CFR Part 11 compliance.
  • Collaborate with vendors and IT department on upgrades and improvements.
  • Collaborate with IT for Installation and validation of new software revisions as they are released. Partner with the laboratory staff for troubleshooting.
  • Lead and coordinate technical issue investigations and actively participate in OOS investigations related to instruments and software failures.
  • Collaborate with IT department for technology resolution implementations.
  • Actively participate on change control by following procedures and work instructions.
  • Develop SOP’s and policies for laboratory computer and LIMS applications.
  • Stay up to date on advances in the software and technology; provide appropriate training to new and current employees as needed.
  • Manage and execute the calibration, maintenance and qualification programs for analytical instruments.
  • Document, investigate and troubleshoot any out of calibration or unplanned maintenance for laboratory equipment
  • Establish utilization metrics and ensure no equipment downtime
  • Support the acquisition of new laboratory equipment, introduction of new technology and overall laboratory design and set-up

EDUCATION/EXPERIENCE.

  • Bachelor’s degree in Chemistry or life sciences. A minor in computer sciences is helpful.
  • Three (3) to five (5) years’ experience in laboratory operations, LIMS administration, chromatography data systems, analytical equipment and techniques or equivalent training and experience.
  • Knowledge of data integrity concepts, cGMP, 21 CFR Part 11, and computer system validation (GAMP).

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