Our client, a leading pharmaceutical company, is hiring a Labware LIMS Specialist and QC System on a contract basis.
• Execute, create or revise validation documents (i.e. UAT, URD, FRS, etc.) as applicable.
• Support Business buildouts and LIMS changes
• Work with the site teams through the governance council to define release scope.
• Support UAT execution in conjunction with validation efforts.
• Works with the developer teams to verify that requirements are understood and delivered.
• Design, review and/or execution of user acceptance testing (UAT) protocols.
• Act as a Labware system Super User to support changes and end user process issues.
• Provide first-line operations support to end users
• Provide first line coordination with Local IT/Tech support and system admins
• Assist with errors and solve problems with minimum guidance; perform simple data fixes.
• Support site projects and goals where applicable to streamline testing.
• Maintain and update master data objects
• Gathers documentation for the collection of Master Data using the LIST Template(s).
• Standardizes and harmonizes master data per standards documented in the MD Configuration Standards SOP.
• Work iteratively with the site SMEs to develop consistent and accurate Master Data.
• Reviews organized, standardized, and harmonized master data prior to build and provides verification of completed master data as needed.
• Performs all activities in compliance to cGMP requirements and applicable standards and procedures.
• Comply to EHS rules and safe work practices per applicable procedures.
• Create and maintain local LIMS related standards and procedures
• Own or support change controls for LIMS changes
• Lead or support investigations in case of LIMS-related deviations
• Participate in inspections by health authorities and in corresponding preparation as LIMS SME.
Education: Bachelors degree
1) Laboratory Information Management System (LIMS) experience focus on Master Data Building – Labware highly preferred.
2) Good Manufacturing Practice (GMP) experience or other GxP experience.
3) Microbiology or Analytical Laboratory experience.
Interview: Panel interview – around 30 minutes in length.