Lab Systems Administration
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.
- 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
- 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).