This is located in Morris County
base of $110k+15% bonus
Systems Analyst/Developer III
Job Description
Under limited supervision, responsible for planning, managing, leading and executing technical activities related to the implementation and production support of electronic submissions software/systems. Interfaces with business users and functional analysts to identify and document the Company's business requirements and ensures realization through the development of value added enhancements while conforming to the system development life cycle. This is the senior-level position in the Systems Analyst/Developer class series.
- Evaluates the requirements and provides custom solution to support critical business operational and reporting processes, Leads team in analyzing the information and prioritizing the requirements to support the business needs.
- Evaluates system impact in consultation with the business, IT management, regulatory, IT development, quality assurance ,and validation teams. Partners with functional business system analyst and IT management to identify necessary department resources to meet defined objectives.
- Participates in strategic customer meetings to review and evaluate new technical challenges that are required to improve operating efficiencies and/or add business benefits.
- Develops detailed design specifications for projects and enhancements.
- Analyze and develop data mapping and migrate data to integrate different systems.
- Creates technical process models based on requirements in order to determine the completeness of the information and process components.
- Performs required documentation according to corporate standards (CSOPs, CFOR, etc.) and Operations Manuals (OM-IT).
- Designs and develops test plans (e.g. test objectives, test cases, test data, test scripts) for executing unit.
- Acts as an internal resource for the consultation to other department members to provide expertise and possible solutions to resolve business needs.
- Performs system configuration and integration testing including the functionality, performance and fit to ensure that it meets the original requirements and works within the defined constraints.
- Performs other duties as assigned.
Qualifications
- Seven (7) to ten (10) years related work experience, preferably in a R&D or Regulatory Affairs environment, or an equivalent combination of education and experience.
- Knowledge of electronic Common Technical Document (eCTD) systems.
- Good functional knowledge of FDA and Regulatory requirements.
- An understanding of XML and prior experience with Oracle database.
- Ability to monitor system performance and identify system bottlenecks.
Required Knowledge and Skills:
Knowledge of:
- Software development lifecycle (SDLC) experience and testing methodologies, processes and tools for testing of functionality, including unit, integration, system, and regression testing.
- Creating and monitoring batch jobs, and converting system data.
- Creating, writing and compiling reports utilizing various report writing tools and technologies.
- Key directional trends and emerging technologies in the IT industry.
- Current Good Manufacturing Practices (cGMP), Food and Drug Administration (FDA), GXP and other regulatory requirements.
- Current Company policies and procedures, including safety rules and regulations.
- English usage, spelling, grammar and punctuation. Skill in:
- Communicating clearly and concisely, both orally and in writing.
- Establishing and maintaining effective relationships with individuals contacted in the course of work.
- Complying with all current Company policies and procedures, including safety rules and regulations.
- Working independently, with little or no supervision.
- Participating in small to medium sized projects.
- Managing multiple tasks and duties.
Education Bachelor's degree in Computer Science, or equivalent, from an accredited college or university.
Ray Lancaster
908-526-5440
RFL@Lancasterinc.net
www.LancasterAssociates.net
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