IT Systems Specialist

Job Code:

P1080

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JOB DESCRIPTION

We are looking to add a talented IT Systems Analyst to our dynamic, growing, and passionate EITS department at Matica Biotechnologies, based in College Station, TX.


The IT System Specialist is responsible for the deployment, maintenance, and troubleshooting of systems and software platforms at Matica Biotechnologies. The incumbent is responsible for the development and implementation of maintenance procedures and monitoring of the system’s health and performance.


Tasks include assisting with implementation, configuration, validation, and training on each assigned system. This position will assist in the generation and maintenance of Key Performance Indicators (KPIs) for assigned systems, utilizing data analytics tools. The individual will serve as a subject matter expert (SME) for each assigned system.
A successful candidate will have experience with a wide Verity of systems utilized in Laboratories and General Business. knowledge of CAPA, Deviations, Investigations, Audits.


Excellent listening, oral and written communication skills. A willingness to solve complicated problems and drive projects through to completion, and strong analytical skills to study problems and records and identify solutions. Individuals should have a team-oriented attitude to help other colleagues and departments with technical problem resolution.


Strong interpersonal communication and relationship-building skills. Ability to manage time and effectively prioritize numerous projects at a time. The ability to work as part of a team is highly valued.


This is a full-time position.

RESPONSIBILITIES

  • Responsible for identifying and implementation for assigned systems for Matica

  • Can be Point of contact for vender interaction for assigned systems as needed.

  • Will be point of contact for trouble shooting and issue resolution for internal customers.

  • Responsible for development of SOP/Work Instructions for each system as applies to the management of the system and generation of KPIs.

  • Responsible for configuration and set up of assigned system(s). This includes, but is not limited to creating users, configuring systems to meet regulatory, quality and Business needs with assistance from vendors or other appropriate subject matter experts.

  • Responsible for development of training tools for each system as well as providing training/coaching to employees as needed.

  • Responsible for assisting with the validation of each system.

  • Responsible for maintenance for KPIs for each system.

  • Responsible for tracking and trending aspects of the systems and provide reports to management identifying risks and trends on a routine basis.

  • Prepare functional and Management Review metrics for identification of negative trends. Conduct analysis of identified negative trends and propose/implement necessary corrections to address and present to Management team.

  • Facilitate risk assessments for site using applicable tools (FMEA, HAACP, SIA, etc.)

  • Maintains tracking mechanisms to support the various systems elements and ensures visibility throughout the organization.

  • May be requested to Support other activities as needed.

QUALIFICATIONS

  • Minimum of a Bachelor’s Degree in Computer Sciences, IT, Management, Business, or a Life Sciences discipline with 3+ years of Systems Analysis experience. Master’s degree preferred.\

  • +3 years' experience within the biologic, biopharmaceutical, or regulated pharmaceutical industry and experience in system analysis and administration functions preferred

  • Familiarity with CSV and GAMP

  • Working knowledge of FDA, ISO and EU Regulations as they apply to systems desirable.

  • Experience with preparing user stories, process flow diagram, wireframes

  • Working experience with agile development methodology, processes, and tools

  • Experience implementing software solution on Cloud as well as on prem

  • Exceptional skills when communicating complex business and technical concepts with the business users, development team and management

  • Have the knowledge, and ability to apply basic scientific and regulatory principles systems.

  • Experience on 21 CFR Parts 11 data integrity and compliance systems