Business Systems Specialist

Job Title:- Business Systems Specialist

Location:- Boston, Massachusetts (5 days onsite)Only local

Duration:- 6+ Months

Please provide two prior work references (work email and work phone number) along with photo ID.

NoH1B

Contract

Job Description

• ENVIRONMENTAL MONITORING AND UTILITIES MONITORING ARE A MUST!!!
• Skills of Master Data management in LabVantage LIMS Systems, together with Data Analysis/Data Management.

GENERAL POSITION SUMMARY:

• The Business System Specialist 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 Company Cell and Gene Therapy sites (LC1, VCGT at VMC 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 Company internal policies and procedures.
• The Specialist is also responsible for stakeholder management, across functional lead.
• The Specialist is responsible for supporting the CGTVMC site processes from LIMS perspective.
• The Specialist will drive the LIMS
• EMUM master data process from the very beginning to the end including change control management, master data verification, data migration etc.

KEY RESPONSIBILITIES:

The responsibilities of this position may include, but are not limited to, the following:

• Work with a project team to identify, capture and update all EMUM master data for the operations within VCGT at VMC site.
• Leads QC, QA and MFG departments in the build and/or revision, review, demo and approval of LIMS master data, including but not limited to products, sampling plan, specifications, methods, sample points, and LEStemplates in LIMS, per global and local LIMS procedures.
• First-line support for end-user LIMS LES templates and data entry issues, COA generation, EMUM data module etc.
• Support in the development, implementation, enhancement of the overall process for requesting, creating/revising, and reviewing master data for VCGT at VMC site facilities.
• Assist in the development and implementation of a site process for the scheduling and status tracking of all sites LIMS EMUM Master Data.
• Work with the site LIMS Administrator and Business Owner to maintain site and global requirements of LIMS.
• Participate in the development and/or revision of VCGT Standard Operating Procedures.
• Corporate with training for end users to use the system.
• Collect digital platform business requirements, user story and use cases, support user acceptance testing as needed.
• Act as digital platform superuser and coordinate with business subject-matter experts from different levels for business needs.
• Responsible to master data module maintenance and perform system master data related impact assessment and taking change actions.
• Build instruments and consumable including critical reagents master data in LIMS system.

MINIMUM QUALIFICATIONS:

• Bachelor's degree in technology discipline or equivalent in technology or science discipline or equivalent.

• Combined degrees and/or experience in fields of biology, data analysis, Bioinformatics is preferred.

• Typically requires 1- 3 years relevant experience in the Life Sciences, or the equivalent combination of education and experience.
• Knowledge of LabVantage master data and system usage functionality requires at least 1 years' experience.
• Familiarity with Environment monitoring and Utility monitoring program within a GxP pharmaceutical manufacturing environment.
• Experience of GxP laboratory and Manufacturing process.
• Must demonstrate ability to work in a team environment and willingness to assume additional or new responsibilities readily.
• Must detail oriented pay close attention and notice minor details.
• Effective communication skills, both verbal and written. Knowledge of regulated systems general level of understanding of systems validation.
• Skills of Master Data management in LabVantage LIMS Systems, together with Data Analysis/Data Management.
• Capable and comfortable multi-tasking between concurrent projects.