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Company Description

LabAnswer 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.

LabAnswer has architected, implemented, deployed and/or supported hundreds of major scientific informatics systems across more than a thousand laboratories. LabAnswer 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 LabAnswer 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.

Travel Requirements: This is a remote position so the candidate can live anywhere in the USA. The position will require 11-25% travel.

Job Description

Job Description:

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 is 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.

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

Qualifications

Minimum Qualifications:

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 Desired Qualifications:

3-5 Years of consulting experience

Certified Business Analysis Professional (CBAP) certification FDA Project Information:

LabAnswer 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 Managements 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.

  Travel Requirements: This is a remote position so the candidate can live anywhere in the USA. The position will require 11-25% travel.

Additional Information

We offer comprehensive benefits to regular full-time employees including but not limited to:

Unlimited ceiling for professional growth opportunities within LabAnswer

You will also have opportunities to take advantage of training programs to advance your career; our extensive online library includes a assortment 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 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

Strong company values of team work, culture and values, personal and professional development, work-life balance, and recognition

Competitive compensation with opportunities to participate in employee bonus plan and travel bonus plan

At LabAnswer we offer a very competitive compensation package based on experience and education. We are looking for exceptional people to join our team, those who are looking to join an organization for the long term. We invite you to visit www.labanswer.com to review our Employee Value Proposition and Philosophy, and welcome you to apply, or refer a candidate to apply, through our careers page for employment consideration.