LIMS BA (LabVantage)

Sr. Business Systems Specialist

• Fully onsite in Boston
• 6 months
• LIMS BA (LabVantage)

General position summary:

• The Business System Specialist Senior will be responsible for the creation and revision, as well as review and approval of LIMS master data within the LabVantage Laboratory Information Management System (LIMS) implemented at the client site for the GxP LIMS system.
• This position will be responsible for providing end-user support for EMUM program as well as compliance with global client internal policies and procedures.
• The Sr. specialist is also responsible for stakeholder management, across functional lead.
• Drive the LIMS master data including EMUM process from the very beginning to the end including change control management, master data verification, data migration etc.

Requirements

• Strong working knowledge of MUMAPSAPQ processes.
• MU – Method/Manufacturing Unit (sometimes “Manufacturing Unit”)
• MAPS – Manufacturing and Packaging Standard (or sometimes “Master Action Plans”)
• APQ – Analytical Procedure/Process Qualification or Assessment of Product Quality

• Experience in XP process manufacturing, MOM, and QC lab workflows.
• Must be detail-oriented, able to manage accurate and compliant data in GxP systems.
• Ability to build and manage specifications in a pharmaceutical manufacturing setting.
• Experience working across QA, QC, DT, and other cross-functional teams.
• Ideal candidates will have relevant pharma/biotech experience, preferably with LIMS/LabVantage and regulated EMUM processes.