LIMS SME, Business Analyst

Summary

Join LabAnswer as we pursue a contract with the Food and Drug Administration (FDA) Office of Regulatory Affairs (ORA) for the continued implementation, deployment, integration, training, testing and support of FDA’s Laboratory Information Managements System (LIMS). We are seeking an LIMS SME/Business Analyst to provide support for an enterprise StarLIMS implementation.

Requirements

• LIMS and/or ELN experience, StarLIMS preferred
• BS + 1 yr experience for Jr Level / BS + 5 years experience for Sr Level
• Excellent verbal and written communication skills
• Sr. Level - Demonstrated exp implementing enterprise data capture/management technologies
• Experience implementing technology under a defined corporate and compliant methodology
• Expert understanding of computer and application architecture and technology
• Strong analytical and problem solving skills

Responsibilities

• Work with end users and management to analyze and document user needs
• Participate in and facilitate meetings
• Work with the project team and FDA leadership to identify data needs for LIMS and/or ELN functionality
• Provide strategic direction to the IT, Scientific, and Management teams
• Define data migration requirements
• Create and maintain SDLC & EPLC documentation
• Contribute in all areas of system implementation including but not limited to vendor interaction, system compatibility, change control, qualification, deployment, and training
• Work with project teams to ensure compliance with regulatory requirements and internal policies and processes
• Develops plans and strategies for the LIMS/ELN
• Analyzes user interfaces / functional needs and requirements
• Maintain hardware and software performance tuning, analyze workload and computer usage, maintain interfaces with outside systems, analyze downtimes, analyze proposed system modifications
• Analyzes Problem and information to be processed
• Defines the problem, and develops system requirements and program specifications from which programmers prepare detailed flow charts, programs, and tests
• Coordinates closely with programmers to ensure proper implementation of program and system specifications. Develops, in conjunction with functional users, system alternatives
• Possesses requisite knowledge and expertise in the professional community that the Government is able to qualify the individual as an expert in the field for an actual TO
• Demonstrates expertise with LIMS, including integration with workflows outside of laboratories and provides expert analysis advice and recommendations

Benefits

• Unlimited ceiling for professional growth opportunities within LabAnswer
• Comprehensive health and welfare programs to fit your individual or family’s needs
• Health Insurance
• Dental Insurance
• Vision Insurance
• 401(k) Retirement Saving that includes a generous employer match
• Paid Time Off (vacation, sick, holiday)
• Company Paid Life Insurance
• Company Paid Short and Long Term Disability Insurance
• Wellness Plans and Rewards