Senior Quality Systems Application Analyst

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Simtra BioPharma Solutions

Site WebLinkedInTous les Emplois

1001 - 5000 employés

Fondée en 1958

🧬 Biotechnologie

💊 Pharmaceutique

Biotechnology • Pharmaceuticals • Manufacturing

Simtra BioPharma Solutions est une entreprise dédiée au développement et à la fabrication de produits injectables stériles. Avec des installations à Bloomington, Indiana, aux États-Unis, et à Halle/Westfalen, en Allemagne, Simtra travaille en étroite collaboration avec ses clients, depuis le développement de la formulation jusqu'à la production clinique ou commerciale. L'entreprise offre des services complets, notamment le développement de cycles de lyophilisation, le transfert de technologie et les opérations de remplissage/fini, tout en proposant diverses options de livraison de produits comme des flacons liquides, des flacons lyophilisés et des seringues pré-remplies. Simtra s'engage à respecter des pratiques de fabrication de haute qualité, en étant conforme aux normes cGMP et en utilisant des processus certifiés ISO 14001 pour garantir la qualité des produits, qui sont distribués dans plus de 120 pays.

Description

• Provides technical project leadership in the planning, design, development, testing, and implementation of application software. • Conducts software application testing and other preparation for software upgrades or new software implementation • Monitors, analyzes, plans, and assists end-users with the implementation of new software releases and upgrades. • Researches system enhancements and executes implementation. • Conducts database analysis; researches and analyzes problems with applications and resolves or formulates solutions. • Provides leadership in problem solving, which requires the consideration of the IT strategic plan and short term goals, the means by which to solve the problem, and development of associated action plans. • Work with vendors to ensure system operability/functionality and to ensure success of system implementations and upgrades. • Reviews projects, analyzes business requirements, recommends system changes, writes specifications and implements application changes to address changing application and end user requirements. • Contributes to ongoing process to integrate end users requests with software functionality to address changing. • Creates and maintains technical documentation and architecture diagrams as required. • Analyzes and provides recommendations relating to application configuration and functionality of systems to ensure reliability for current and/or future use. • Works directly with project managers to understand application objectives, develop scope of project, outline effort projections, determine schedules, and finalize plans. • Establishes and enforces standards, policies and procedures for Quality/Lab Systems related application systems. • Participate in the development and implementation of the information technology goals, objectives, policies, and priorities. • Assist in assessing the strategic direction of information technology and in developing strategic plans for use of new technology.

🎯 Exigences

• Bachelor’s degree in Information Technology or Computer Science or equivalent experience in an Information Technology environment. • Five years experience in Quality Systems discipline as an Information Technology Analyst or a related function performing • User support • Training • Supporting installation, development, and maintenance of the business application software and servers, including the development of associated metadata and user interfaces • PMP certification preferred • Support large scale complex software application(s) • Experience configuring Veeva application • Experience in integrated SaaS enterprise solution network and infrastructure environment • Demonstrates diagnostic skills and expertise to assist with problem determination and solution across the enterprise solution environment. • Analyze software application problems and issues and drive to root cause solutions • Create and meet deadlines • Deal with multiple high priority issues simultaneously • Develop and manage projects of significant scope with considerable impact on the organization • Deal with controversial or sensitive issues • Perform analysis at a high level • Excellent written and oral communication skills

🏖️ Avantages

• Day One Benefits • Medical & Dental Coverage • Flexible Spending Accounts • Life and AD&D Insurance • Supplemental Life Insurance • Short and Long-Term Disability Insurance • 401(k) Retirement Savings Plan with Company Match • Time Off Program • Paid Holidays • Paid Time Off • Paid Parental Leave and more • Adoption Reimbursement Program • Education Assistance Program • Employee Assistance Program • Community and Volunteer Service Program • Additional Benefits • Voluntary Insurance Benefits • Vision Coverage • Accident • Critical Illness • Hospital Indemnity Insurance • Identity Theft Protection • Legal and more • Onsite Campus Amenities • Workout Facility • Cafeteria • Credit Union