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. Were 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 youre 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 teams 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).

Hybrid

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 dont 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.