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Labware LIMS Specialist and QC Systems

Posted 16 days ago

  • Expiry Date: 12 December 2022
  • Referral: 219795@accuick.com

Job Description:

  • 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.

About ASK: ASK Consulting is an award-winning technology and professional services recruiting firm servicing Fortune 500 organizations nationally. With 5 nationwide offices, two global delivery centers, and employees in 42 states-ASK Consulting connects people with amazing opportunities

ASK Consulting is an equal opportunity employer. We celebrate diversity and are committed to creating an inclusive environment for all associates.

Contact:

Full Name: Akash Mehra

Email ID: akashm@askconsulting.com

Phone: 908-224-9613