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Business Analyst

Astrix Technology Group, LOS ANGELES CA

This job is no longer available.

Responsibilities (include but are not limited to):

 

·         Work collaboratively with Quality, Manufacturing, LIMS Admins, Developers, Vendor and IT at all levels to meet project deliverables and timelines

·         Interact with the Laboratory operations group to support LIMS implementation and ongoing support for new module implementations and/or installation of new capabilities

·         Work with the IS and IT groups to integrate LIMS in a cGMP environment.

·         Partner with IT and laboratory organizations, support users by responding to change requests and training needs

·         Comply with Software Development Lifecycle (SDLC) and company’s Computer Systems Validation (CSV) process and procedures

·         Work collaboratively to manage, analyze and maintain complex master data and custom configuration in LIMS system

·         Actively participate in all phases of application implementation, including ownership of key deliverables such as

·         User Requirements Specifications

·         Function Specification

·         Design Specifications

·         User acceptance testing

·         Validation documentation

·         Deployment support

·         Assist in developing Standard Operating Procedures (SOPs) for global and local Laboratory Information Management (LIMS) Systems

·         Identify and recommend areas of process improvement

·         Perform knowledge transfer and provide ongoing leadership, to support project go-live and beyond, operations and support activities

 

Requirements:

·         5+ years’ experience analyzing business requirements and supporting information systems projects

·         Biotech/Life Science industry experience is strongly preferred

·         Experience with LabVantage LIMS strongly preferred

·         Familiarity with analytical methods such as Cell Based Assays, Binding Assays, Microbiological assays, HPLC, ELISA and other routine analytical assays.

·         Experience in areas such as sampling, pharmaceutical quality control lab, laboratory data and reports (C of C, C of A), data management, change control, GLP/GMP and compliance.

·         General understanding of pharmaceutical GMPs and 21CFR Part 11 regulations

·         Excellent interpersonal, verbal and written communication skills including facilitating small group discussions and clarifying requirements

·         Excellent technical writing experience in a regulatory environment, including experience in writing detailed requirements, user stories, business processes, technical specifications, test protocols and reports, for both custom and commercial off-the-shelf (COTS) systems

·         Experience in a manufacturing environment preferred. Experience with supporting a multi-site enterprise system with master data (LIMS, MES, PLM) preferred

·         Comfortable in a fast-paced growing company with minimal direction and able to adjust workload based upon changing priorities

·         Familiarity with Computer Systems Validation and GxP processes preferred

·         Ability to work off hours as needed

·         Ability to travel to and work at multiple locations throughout the greater Los Angeles area 

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