Principal Quality and Regulatory Business Analyst

The job is a business/technical position in information technology that will work closely with members of Quality and Regulatory business functions to insure reliable, effective and efficient operations of all business Quality Assurance and Regulatory Affairs related systems. This includes all systems supporting Learning Management, Document Management, Laboratory Management, Event Tracking, Supplier Compliance, Materials Compliance, Regulatory Information Management, Regulatory Document Management, Regulatory Filings, etc.

Work Schedule: Monday - Friday 8am -4:30pm, Hybrid schedule - 4 days onsite in either St. Louis MO or Noblesville IN and 1 day remote.

• Strong system analysis capability derived from software development experiences
• Business acumen and the ability develop and manage third parties to service level agreements
• Experience working with Quality and Regulatory systems in a regulated industry
• Capable of working with the business to develop system rationalization and optimization strategies
• Experience working with Systems Development Life Cycle methods (water fall & agile)
• Participates in staff meetings and team meetings as required.
• Develops understanding of general industry usage of supported technologies.
• Develops basic understanding of business processes and business dependencies on supported technologies.
• Develops relationships within I/S and with supported customers to improve collaboration and teamwork necessary to accomplish organizational objectives.
• Participates in a development planning process where employee career goals are defined & understood and development activities are incorporated into the employee objectives.
• Other duties as assigned with or without accommodation.
• Must maintain operational compliance with US and international regulatory agencies and guidelines (i.e. FDA, DEA, EU, HC, TGA, PIC/S, ISO, USP, NRC, cGMP, etc.).

• Bachelor Degree or Technical School degree in Information Technology, Business or related degree program; work experience in lieu of degree acceptable
• Ten or more years of information systems experience with a demonstrated capability in Quality and Regulatory Systems is required
• Experience with GMP and Validation requirements is required
• Strong systems analytics with the ability to manage large number applications is required
• Ability to work independently to gather, process and document business requirements and translate into functional solutions that meet the business requirements
• Ability to manage multiple projects simultaneously and balance priorities effectively
• Strong interpersonal skills with the ability to collaborate with members of the business and third party support personnel to develop system requirements and resolve system issues
• Strong hands-on analysis and problem solving experience preferably with Quality and Regulatory systems is required

Working Conditions:

• Willingness to work in plant producing radioactive materials and requiring all employees to participate in safety programs designed to minimize potential and/or actual exposure levels.
• Responsibilities include the ability to lift up to 70 pounds, kneeling, crouching, twisting the upper body, walking, bending, stooping, pushing, pulling, reaching, must be able to physically negotiate stairs and evacuation ladders with or without accommodation, wear and operate safety equipment, enter vessels, and inspect equipment.
• Material handling devices (e.g., hand truck, fork truck, and conveyors) are used when possible, however, use of proper lifting and movement techniques is necessary to prevent injury.
• Must be willing to wear a variety of Personal Protective Equipment (PPE) and hearing protection as needed.
• May be required to sit or stand for long periods of 8 hours a day while performing duties.
• Must possess good hand-eye coordination; close attention to detail is required.
• Must be able to work indoors and outdoors with exposure to mechanical/moving parts, hazards including corrosive, flammable and toxic material, dust, dirt, odors, and irritants.
• Willingness to complete safety training within allotted timeframes, and work in a team-based environment.
• Must be able to work outside of regular work hours, including off shift, weekend, and holiday work as business needs require.