System Analyst II

Cook MyoSite, Inc., part of the Cook Group, Inc. family of companies, is on a mission to make regenerative medicine a part of everyday medicine. We’re investigating our core technology, autologous muscle-derived cells, for the potential treatment of several muscle-related disorders. We at Cook MyoSite have the potential to make a difference in the lives of countless people around the world, and we also have the potential to make a difference in yours. Joining our team is an opportunity to ignite your passion, grow your potential, and define your purpose. If you’re curious, motivated by helping others, and driven by integrity, we invite you to apply.

The System Analyst II provides technical subject matter expertise and is responsible for operational ownership of
applications and/or business intelligence solutions on computer systems providing business/IT or manufacturing support (i.e. ERP, eQMS, HRIS, SSRS, Qlik, CRM, etc.)

• Serve as platform owner for applications and/or business intelligence solutions for the duration of a Systems Development Lifecycle (SDLC); has responsibility for the delivery, integration, modification, maintenance, and retirement of the application and/or business intelligence solution.
• Work with business analysts and departmental system owners to define technical project scope and the user requirements specification for a proposed solution.
• For new / updated applications and/or business intelligence solutions; authors application functional specifications, configuration and data mapping documents, and commissioning documents (i.e. unit tests, software verification tests).
• Support the delivery of applications and/or business intelligence solutions by either configuration of parameters and workflows to define behavior, and/or programming (i.e. C#, SQL, Python, etc.) to extend capabilities.
• Lead solution demonstrations and works with departmental system owners’ and end-users to ensure user requirements are met.
• Actively participate in validation risk assessments and various reviews meetings supporting solution delivery.
• Execute commissioning; supports computer system validation team’s installation qualification (IQ), operational qualification (OQ), and performance qualification (PQ) activities as needed.
• Function as a system administrator and/or data administrator.
• Develop reporting tools to support quality, including configuration to support data trending and analysis.
• Ensure data integrity by monitoring system performance, security, and data metrics.
• Create and review Standard Operating Procedures (SOPs) and training materials; conducts training for SOPs.
• Practice and stays current with ISPE GAMP best practices, FDA GxP regulations, and applicable ISO standards.
• Coordinate activities with external consultants.
• Monitor project progress by tracking activities; resolving problems; publishing progress reports; recommending actions.

Undergraduate degree in Computer Science, Engineering, Information Systems, Business Systems, or 6 years direct, relevant experience in development, delivery, and support of enterprise-wide computerized system solutions to provide a comparable background.

Advanced proficiency in MS Office, specifically, advanced knowledge of Project, Adobe, OneNote, Excel, Word and PowerPoint; Expert in Outlook
Basic understanding of cGMP, 21 CFR Part 11, and related regulations associated with Bio/Pharmaceutical product manufacturing
Ability to learn and support new systems and applications, and the ability to provide technical training to end users.

Minimum of 1-3 years' experience in one or more of Applications Engineering or Configuration, Application Delivery, Software Development, Data Warehouse Development, Software Requirements Analysis, Information Analysis, or Software/IT Support.
Minimum of 1-3 years' experience with packaged software tools (MATLAB, LabView, solidThinking, etc.) or programming languages (C, C++, C#, SQL, Python, Java, JS, etc.) or traditional statistical software tools (e.g. JMP, SAS, R, Minitab).

• Exemplifies Cook MyoSite Core Values
• Maintain regular and punctual attendance
• Must maintain company quality and safety standards
• This position requires an ongoing commitment to upgrading knowledge, job skills and abilities in addition to competency related to all duties and responsibilities listed above.
• Ability to work in collaborative and independent work situations and environments with minimal supervision
• Maintain composure and competence under stressful situations; demonstrate flexibility and adaptability
• Must work and interact effectively and professionally with and for others throughout various levels of the global organization to achieve company goals
• Trainability
• Must have effective verbal, written and interpersonal skills
• Able to prioritize and operate proactively

• Experience in developing solutions in enterprise class IT systems (i.e. ERP, eQMS, HRIS, SSRS, Qlik, CRM, etc.).

• Experience delivering and/or supporting CRM, eCommerce, websites, or content management systems.
• Experience working in a highly regulated environment (Pharmaceutical, Medical Devices, Financial).

Full Time Remote

Physical Requirements:

• General office, warehouse and laboratory setting

• Ability to conduct and hear ordinary conversation and telephone communication.
• Must be able to work extended hours beyond normal work schedule to include, but not limited to, evenings, weekends, extended work hours and/or extra work hours, sometimes on short notice as required.
• Ability to work under specific time constraints.
• Must be able to sit at desk, in meetings and/or work on a computer for long or extended periods of time.
• Visual and manual acuity for working with computers and equipment.

Employee that does not interact with Healthcare Professionals
Compliance with all policies of the company including without limitation the Cook Employee Manual, Cook Code of Conduct, Quality System Manual, Cook Electronic Information Policy and HIPAA regulations.

At Cook MyoSite, we don’t just accept difference — we celebrate it, we support it, and we thrive on it for the benefit of our employees, our products, and our community. Cook MyoSite is proud to be an equal opportunity workplace.
This job description features the essential and critical functions of the position described and is not an exhaustive list of tasks and/or responsibilities. This may be subject to change at any time due to reasonable accommodation or other reasons.