IT Applications Systems Analyst

Position Title:  IT Applications Systems Analyst Department: IT Applications
Classification Exempt Work Location: Global

The following includes data on essential functions, as well as physical, mental, academic and experiential requirements for the job defined herein. This description is meant to serve interviewers, applicants, managers and incumbents as a reference tool for determining whether applicant or associate qualifications are sufficient to perform the tasks and assume the responsibilities as described. Some aspects of the job may change over time, according to business needs, which changes may not be recorded herein at this time.
Position Summary:
This IT Application Systems Analyst position will provide software and IT system support to the Decatur plant. Responsible for daily administrative support, troubleshooting and issue resolution, software upgrades, technical documentation and end-user support tasks for a range of hardware and specific software packages. This specialist will collaborate closely with business process owners in Quality, Regulatory, Laboratory and R&D spaces. This individual will provide technical support and system configuration to meet business process needs and regulatory compliance expectations. The individual will work understand business processes, business needs and opportunities for enhanced solutions to drive improvements in efficiency, compliance and end user experience.

Essential Functions:
• Serve as IT System Owner for Quality, Laboratory and Regulatory IT Applications, providing lifecycle management from system selection through final decommissioning.
• Drive successful, timely and efficient system implementation, including project coordination, technical support, vendor management and project timeline/budget adherence.
• Lead process improvements and change management for assigned applications, to assure realized compliance and business value of such applications.
• Provide routine administrative and operational support to computer systems throughout the laboratory, R&D, RA and Quality organization including but not limited to
• Operate Thermal Mapping equipment, i.e., Kaye in performing temperature mapping on sterilizers, depyrogenation tunnels, lyophilizers, incubators, stability chambers, areas, rooms, etc.

  • Chromatography Data Systems such as Thermo Chromeleon, Waters Empower, and Agilent OpenLab and EZ Chrom Chromatography Data Systems
  • Niche Laboratory data acquisition, processing and reporting systems associated with specific laboratory equipment such as LabX Titration, ColorQuest, Omnic FI-IR, ICP- MS,
  • Quality software such as Calibration Manager (Calman/AMMS), Scientek iStability and other LIMS software.
  • Compliance software such as TrackWise Enterprise, eQMS, EDMS VeevaVault QMS/QDocs and Learning Management Systems.
  • Optel line master and serialization product suite.
• Propose application-based solutions for business processes to enhance efficiency, compliance, and visibility to processes.
• Partner with business process owners, and key IT stake holders for effective collaboration throughout system design, configuration, deployment and maintenance.
• Solicit end-user feedback to drive collaborative value-added continual improvement within applications in assigned functional areas.
• Provide application trouble shooting support, partnering with global IT resources, vendors and other available SMEs to resolve issues, investigate failures and implement appropriate preventative actions.
• Collaborate with quality team to provide SME contributions related system-failure related deviations, providing insight into root cause analysis, and partner with business to identify most appropriate CAPA for risk mitigation.
• Publish business success playbooks and associated tools for system use/end-user support
• Evaluate system use through a combination of system reporting data analysis and end user feedback
• Document resolutions in a manner to facilitate appropriate creation of internal knowledgebase for applications.
• Application lifecycle maintenance including but not limited to, review application release notes, with business process SMEs and data system specialists to advise on change impact, and upgrade recommendations to maintain systems within infrastructure standards, where possible.
• Desktop / server / networking configuration, support and change management in a highly- regulated environment.
• Other duties, as needed to support continued operational excellence, compliance.

Minimum Qualifications:
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

Successful candidates for this role will be passionate about providing excellent customer service, have a strong desire to learn new technologies and further their education in order to grow with the company. Recognizing that Quality, Laboratory, Regulatory and R&D are critical to any pharmaceutical manufacturing organization, this position will be a highly valuable and rewarding contributor to the continued success of Rising.

  • Requires effective interpersonal skills due to frequent interaction with users.
  • Strong written and verbal communication skills.
  • Customer-oriented attitude and experience.
  • Sound understanding of the pharmaceutical manufacturing industry and associated regulations.
  • Ability to work with users at all levels on a variety of technical initiatives and work in a cross- functional team.
  • Able to multi-task with multiple high-priority projects and flexible timelines and expectations.
  • Able to work independently in an efficient, detail-oriented manner, understanding risk and business impact and prioritizing workloads appropriately.
  • Ability to apply deductive reasoning and analytical thought to understand complicated issues.
  • Ability to receive instructions and follow work rules and company policies, safety and security practices.
Education and Experience:
  • Minimum of Bachelor’s Degree or equivalent years of experience.
  • Minimum 3 years of experience with a diverse range of end-user IT support tasks.
  • Minimum 3 years of experience with R&D, Regulatory, Quality and Compliance software or similar applications in the pharmaceutical or regulated industry.

Physical Demands, Mental Requirements, and Work Environment:
The physical demands described here are representative of those that must be met by an associate to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
Mental requirements include:
  • Ability to apply deductive reasoning and understand complicated issues.
  • Ability to plan and organize.
  • Customer-oriented attitude and experience.
  • Ability to receive instructions and follow work rules and company policies.
  • Ability to follow safety and security practices.
  • Ability to meet deadlines and effectively deal with office stress.
  • Ability to accurately communicate ideas, facts and technical information.
  • Maintain confidentiality of certain information.

The lists under Essential Functions and Additional Responsibilities are not exhaustive, but are merely the most accurate lists for the current job. Management reserves the right to revise the job description and to require that other tasks be performed when the circumstances of the job change. This position description in no way states or implies that the responsibilities and tasks are the only responsibilities and tasks to be performed by the associate occupying this position. S/he will be required to follow any other instructions and to perform any other job-related duties as required by his/her supervisor/manager. Requirements stated are minimum levels of knowledge, skills and/or abilities to qualify for this position. To perform the duties and responsibilities of this position successfully, the incumbent will possess the abilities and aptitudes to perform each task proficiently. Employment decisions, including promotions, transfers and others, are based on meeting all requirements and on organizational needs, the associate’s being in good standing (including lack of disciplinary actions), meeting all applicable performance standards and other non- discriminatory criteria. The methods of fulfilling requirements are subject to possible modification to reasonably accommodate qualified individuals with disabilities. THIS DOCUMENT DOES NOT CREATE AN EMPLOYMENT CONTRACT, IMPLIED OR OTHERWISE. WE MAINTAIN AN “AT WILL” EMPLOYMENT.

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