Senior Quality Systems Application Analyst; Remote

Senior Quality Systems Application Analyst (Remote)

Join to apply for the Senior Quality Systems Application Analyst (Remote) role at Simtra Bio Pharma Solutions

Simtra Bio Pharma Solutions (Simtra) is a world‑class Contract Development Manufacturing Organization, partnering with pharmaceutical and biotech companies to bring their sterile injectable products to market. With facilities in Bloomington, Indiana, and Halle/Westfalen, Germany, we offer a wide range of delivery systems including pre‑filled syringes, liquid/lyophilized vials, diluents for reconstitution, powder‑filled vials and sterile crystallization.

Our product types include biologics and small molecules, cytotoxics, highly potent compounds, diluents for reconstitution and vaccines – all directly injected into patients worldwide. As such, there is a strong emphasis on quality and continuous improvement  hold ourselves to the highest quality and regulatory standards.

While our primary focus is cGMP manufacturing, we offer many support services including formulation and development, lyophilization optimization, global regulatory support and secondary packaging. Our teams are driven to help clients scale, innovate and bring life‑changing medicines to patients worldwide.

• Make it HAPPEN – We bring a growth mindset to every opportunity, developing new skillsets and exceeding our expectations and those of our customers.
• Make it TOGETHER – We work as one, respecting each voice and tapping into our unique strengths across teams – so we can solve problems in new ways.
• Make it RIGHT – We hold ourselves to a high standard of excellence, fulfilling our commitments to the customer, their patients, and our team members.
• Make it COUNT – We take pride in our day‑to‑day work, knowing the impact we make – taking on challenges big and small to improve patient health.

As the Senior Quality Systems Application Analyst, you will play a critical role in enhancing the user experiences with cloud‑based quality related applications and ensuring our integrated enterprise solution for the organization. Your responsibilities will include a variety of duties related to the integration, administration, upgrade, testing and support of Quality Systems enterprise software applications. Your ability to translate the requirements of our internal customers into robust solutions will be essential in this role.

• 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 needs.
• 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.
• Participates in the development and implementation of the…