System Analyst III

Posting Date 2 months ago(12/10/2021 3:38 PM)
Requisition ID
2021-10026
Job Location(s)
Pittsburgh PA United States
Travel
None
Position Type
Full Time
Company
Cook Myosite Inc.
Category
Information Technology

Overview

Cook MyoSite, Inc. 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 III at Cook MyoSite Inc. will provide leadership for technical subject matter expertise, and will be 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.).

Responsibilities

• Independently 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).

• Independently 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.

• Executes commissioning; supports computer system validation team’s installation qualification (IQ), operational qualification (OQ), and performance qualification (PQ) activities as needed.

• Functions 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 reviews 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.

• Leads activities with external consultants.

• Leads projects and monitors project progress by tracking activities; resolving problems; publishing progress reports; recommending actions.

Qualifications

• Undergraduate degree in Computer Science, Engineering, Information Systems, Business Systems, or 10+ years direct, relevant experience in development, delivery, and support of enterprise-wide computerized system solutions to provide a comparable background.

• Minimum of 3-6 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 is preferred

• Minimum of 3-6 years' experience with managing Commercial Off-The-Shelf (COTS) systems or use of programming languages (C, C++, C#, SQL, Python, Java, JS, etc.) is preferred

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

• Experience delivering and/or supporting CRM, eCommerce, websites, or content management systems is preferred

• Experience working in a highly regulated environment (Pharmaceutical, Medical Devices, Financial) is preferred

• Experience working per ISPE GAMP 5 best practices and GxP constraints as part of managing Commercial Off-The-Shelf (COTS) systems is preferred

• Knowledge of data integrity concerns and regulations is preferred

• 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

• Advanced proficiency in MS Office, specifically, advanced knowledge of Project, Adobe, OneNote, Excel, Word, and PowerPoint; expert in Outlook.

• In-depth understanding of cGMP, 21 CFR Part 11, and related regulations associated with Bio/Pharmaceutical manufacturing and best practices (e.g. ISPE GAMP).

• Ability to learn and support new systems and applications, and the ability to provide technical training to end users.

• Proficiency or comfort level working with material of a highly technical or scientific nature

 

Physical Requirements:

• Office Setting (no travel): 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.

 

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