LIMS SME​/Business Analyst

Lab Answer is the leading and largest laboratory informatics consultancy; combining science, laboratory, regulatory and information technologies. We have the people, processes, methodologies, IP and experience to deliver comprehensive laboratory informatics solutions.

Lab Answer has architected, implemented, deployed and/or supported hundreds of major scientific informatics systems across more than a thousand laboratories. Lab Answer performs significant laboratory automation work in pharmaceuticals, bio-pharmaceuticals, medical devices, forensics, and life sciences research laboratories spanning research, development and manufacturing/QC operations.

The Lab Answer team has a rare combination of laboratory science, IT, business and regulatory expertise. We specialize in helping companies strategize, architect, implement and support scientific data management and laboratory automation projects.

Remote position; candidate can live anywhere in the USA. The position will require 11-25% travel.

Lab Answer is pursuing 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 Management System (LIMS). We are currently working on the project as a subcontractor. The new contract is anticipated to be awarded in late July, 2016 for a period of 7 years.

There are approximately 6 remote LIMS SME positions.

The LIMS SME/Business Analyst will provide support for an enterprise StarLIMS implementation for the Food and Drug Administration (FDA) Office of Regulatory Affairs (ORA).

The duties for this position are as follows:

• 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
• Create and maintain SDLC and EPLC documentation
• Contribute in all areas of system implementation including 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
• Develop plans and strategies for the LIMS/ELN
• Analyze 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
• Analyze problems and information to be processed
• Define the problem and develop system requirements and program specifications for programmers to prepare detailed flowcharts, programs, and tests
• Coordinate closely with programmers to ensure proper implementation of program and system specifications. Develop system alternatives in conjunction with functional users
• Possess requisite knowledge and expertise for government qualification as an expert in the field for the actual TO
• Demonstrate expertise with LIMS, including integration with workflows outside of laboratories and provide expert analysis, advice, and recommendations

• LIMS and/or ELN experience;
  StarLIMS preferred
• BS + 1 year experience for Jr Level / BS + 5 years experience for Sr Level
• Excellent verbal and written communication skills
• 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

Desired

Qualifications:

• 3-5 Years of consulting experience
• Certified Business Analysis Professional (CBAP) certification

• Unlimited ceiling for professional growth opportunities within Lab Answer
• Opportunities to take advantage of training programs; extensive online library of technical and professional training tools and resources
• Opportunities to work across a variety of industries (Pharmaceutical, Medical Device, Consumer Products, Energy, Environmental, Forensics, Genomics, Government etc.)
• Opportunities to work across a variety of laboratory environments (analytical testing, biotech, clinical trials, forensics, medical device, pharmaceutical, public health and research hospitals)
• Comprehensive health and welfare programs to fit individual or family needs
• 401(k) Retirement Savings plan with generous employer match
• Paid Time Off (vacation, sick, holiday)
• Company Paid Life…