Sr. Business Analyst (ADX-1620) – IT Quality

COMPANY OVERVIEW:

THE COMPANY: ArcherDX, Inc. - www.ArcherDX.com

ArcherDX is advancing molecular diagnostics with a robust technology platform for genetic mutation detection by next-generation sequencing. By combining patented Anchored Multiplex PCR (AMP™) chemistry in an easy-to-use, lyophilized format and powerful bioinformatics software, the Archer® platform enhance genetic mutation identification. ArcherDX provides oncology-focused research products and is pursuing regulatory approval for multiple companion diagnostic assays. ArcherDX is headquartered in Boulder, Colorado. Learn more at www.archerdx.com and follow @ArcherDXInc on Twitter, Facebook and LinkedIn. 

POSITION SUMMARY:
ArcherDX's patented chemistry and powerful bioinformatics software have placed us at the bleeding edge of the fight against cancer and other genetic diseases. You'll join a multidisciplinary team focused on improving and maturing the Information System ecosystem.
ArcherDX has a unique opportunity for the right candidate to play a pivotal role in creating a culture of customer service and innovation for the department. The Enterprise Systems Senior Business Analyst – IT Quality will focus on the Quality and Regulatory function during the implementation of the new ERP system. Assignments will vary across functional areas as business and project deliverables change.

• Act as a Business Analyst and work across the organization with many different departments. In this role, the candidate will gather requirements, guide process mapping with various departments critical processes and help guide software validation initiatives. The role will work in close conjunction with the assigned area. Initially, the Quality group will be the focus. The Sr. BA for Quality will ensure that the application has the necessary process and regulatory controls built in.
• Act as a Data Analyst. Work closely with the ERP system administrator and customers to understand requirements regarding; process, data, and system usage. Provides accurate, real-time data to support business decision making.

RESPONSIBILITIES:

Job performance will involve a variety of activities including, but not limited to the following;

Process Analysis

• Assist Logistics, Operations, Procurement and Quality groups with process design. Ensuring that regulations are built into the business processes and that the processes are fully documented.
• Configure and tune selected applications to support ArcherDX's business processes
• Document system and process interfaces and dependencies
• Lead business UAT. Work with vendors and other third parties to test functionality from end to end. Write documentation to supplement test scripts such as; work instructions, screen layouts, how to guides. Assist functional areas with end user training, software validation and User Acceptance Training.
• Maintain the installed CRM / ERP
• Support system change requests by evaluating, feasibility, risk, and impact.
• Monitor software driven changes and lead re-validation efforts as required.

Regulatory deliverables

• Define, review, execute, and ensure compliance with policies, standards, and procedures related to Computer Systems Validation (CSV) and qualification of systems including infrastructure components.
• Leads project-specific CSV efforts, including assistance with execution of the test plan, assembly of test results into a validation package, and addressing concerns and findings raised by quality assurance personnel.
• Maintain training currency and compliance regarding ArcherDX's Quality Management System, Employee Manual, and Safety procedures.

Data Analysis

• Design, develop and implement environments to support data analytics
• Advises business analysts on methods to query and use data effectively
• Assist with ETL operations and database optimization and validation to ensure data integrity
• Develops reports, dashboards and tools to assist with the development of "Key Process Indicators" or "Objective and Key Results".

EXPERIENCE:

• Between 3 to 5 years’ experience as an IT Business Analyst. Experienced with process analysis, and data analysis (required)
• Demonstrated experience with non-product Computer Systems Validation (CSV) (required)
• Strong technical writing and modeling skills; examples definition of process workflow, work instructions, training material (required)
• Experienced with ERP/CRM systems. (required)
• Strong experience in Quality and Regulatory processes in a life sciences company. (required)
• Skilled in one or more secondary domains; Design, Marketing, Manufacturing, Service, or Finance. (required)
• Demonstrated experience with Commercial Off The Shelf (COTS), system configuration to match business process requirements. (preferred)
• Demonstrated ability to understand business processes, troubleshoot issues, perform root cause analysis and suggest solutions that resolve business problems.
• Demonstrated sense of urgency to help internal customers.

KEY ATTRIBUTES:

• Ability to learn new systems, processes, and technology and apply skills through project work and development of training material
• Ability to work in a fast-paced and dynamic environment
• High energy, self-motivated, approachable and articulate team player.
• Ability to communicate successfully technical concepts to non-technical people.
• Excellent oral and written communication skills.
• Strong interpersonal and team working skills.
• Strong attention to detail demonstrating accuracy.
• Great problem-solving skills; able to anticipate and recognize problems, diagnose root causes and take corrective action to prevent a recurrence.
• Flexibility to adjust quickly and effectively to frequent change and altered priorities.
• Ability to adapt to new technologies and changing environments.

EDUCATION:

• Bachelor’s degree in Computer Science or, equivalent of education and experience sufficient to successfully perform the essential functions of the job may be considered