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Simtra BioPharma Solutions

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Simtra BioPharma Solutions

CAPA Manager

Bloomington, IN · On-site

Simtra BioPharma Solutions (Simtra) is a world-class Contract Development Manufacturing Organization, partnering with pharmaceutical and biotech companies to bring their sterile injectable products ...

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Infographic showing various job openings at Simtra Biopharma Solutions in the United States as of June 2026, with employment types broken down into 100% Full Time. Highlights an 100% Physical job distribution.

Senior Quality Systems Application Analyst (Remote)

Simtra BioPharma Solutions

Remote

Full-time

Posted 11 days ago

Job description

Job Summary:
Simtra BioPharma Solutions is a leading Contract Development Manufacturing Organization that partners with pharmaceutical and biotech companies. The Senior Quality Systems Application Analyst will enhance user experiences with cloud-based quality applications and ensure the integration of enterprise solutions, focusing on software application testing, implementation, and user support.
Responsibilities:
• 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.
Qualifications:
Required:
• 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.
• 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.
Preferred:
• PMP certification preferred.
Company:
Simtra BioPharma Solutions is a pharmaceutical company that manufactures injectables and clinical supplies. Founded in 1930, the company is headquartered in Parsippany, USA, with a team of 1001-5000 employees. The company is currently Late Stage.

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