Job Summary
Main purpose of this position is to guarantee that materials and products are analyzed in compliance with current Good Manufacturing Practices, conform with regulatory requirements and meet all obligatory quality standards both during and on completion of analysis.
This role is responsible for operational and technical support of electronic systems used to perform analytical testing, recording and reporting analytical test results. These electronic systems include chromatography data systems, laboratory information management systems (LIMS) and other associated technologies.
Educational Requirements:
Candidates may hold a degree in Chemistry, Biology, Microbiology, Engineering or a related field. A primary degree in IT combined with at least 5 years experience in a laboratory setting would also be considered acceptable.
Key Responsibilities:
* Act as system administrator for E-Systems utilized in the laboratory
* Act as primary contact with IT regarding system upgrades and validation of electronic systems used across the laboratory
* Have extensive knowledge building with/using one or more of the following key applications: Empower, MODA, Labvantage, Nugensis
* Act as primary contact to global system representatives
* Guarantee that all E-Systems used in the testing of raw materials, in-process samples, intermediates or final products are appropriately validated and remain in an ongoing validated state
* Ensure investigations are undertaken and documented in the event of non-conformance to acceptable quality and/or safety standards
* Review and approve analytical procedures, investigations, and deviations
* Provide guidance and training to other team members on updates to the cGMPs, which pertain to QCL E-Systems testing
* Support the writing of periodic reports and system validation documentation
* Provide technical support to Lab analysts and other technical staff