Job Type: Contract to Hire
PRIMARY FUNCTION: The Senior System Analyst provides leadership for technical subject matter expertise and is responsible for operational ownership of applications and/or business intelligence solutions on computer systems providing business/IT or manufacturing support (i.e. ERP, eQMS, HRIS, SSRS, Qlik, CRM, etc.).
ESSENTIAL JOB FUNCTION/DUTIES • Independently serve as platform owner for applications and/or business intelligence solutions for the duration of a Systems Development Lifecycle (SDLC); has responsibility for the delivery, integration, modification, maintenance, and retirement of the application and/or business intelligence solution. • Work with business analysts and departmental system owners to define technical project scope and the user requirements specification for a proposed solution. • For new / updated applications and/or business intelligence solutions; authors application functional specifications, configuration and data mapping documents, and commissioning documents (i.e. unit tests, software verification tests). • Independently support the delivery of applications and/or business intelligence solutions by either configuration of parameters and workflows to define behavior, and/or programming (i.e. C#, SQL, Python, etc.) to extend capabilities. • Lead solution demonstrations and works with departmental system owners’ and end-users to ensure user requirements are met. • Actively participate in validation risk assessments and various reviews meetings supporting solution delivery. • Executes commissioning; supports computer system validation team’s installation qualification (IQ), operational qualification (OQ), and performance qualification (PQ) activities as needed. • Functions as a system administrator and/or data administrator. • Develop reporting tools to support quality, including configuration to support data trending and analysis. • Ensure data integrity by monitoring system performance, security, and data metrics. • Create and reviews Standard Operating Procedures (SOPs) and training materials; conducts training for SOPs. • Practice and stays current with ISPE GAMP best practices, FDA GxP regulations, and applicable ISO standards. • Leads activities with external consultants. • Leads projects and monitors project progress by tracking activities; resolving problems; publishing progress reports; recommending actions.
KNOWLEDGE, SKILLS & ABILITIES • Exemplifies Company’s Core Values. • Maintain regular and punctual attendance. • Must maintain company quality and safety standards. • This position requires an ongoing commitment to upgrading knowledge, job skills and abilities in addition to competency related to all duties and responsibilities listed above. • Ability to work in collaborative and independent work situations and environments with minimal supervision. • Maintain composure and competence under stressful situations; demonstrate flexibility and adaptability. • Must work and interact effectively and professionally with and for others throughout various levels of the global organization to achieve company goals. • Trainability. • Must have effective verbal, written and interpersonal skills. • Strong interpersonal skills resulting in exceptional rapport with people. Proven success in initiating, promoting, and maintaining strong interpersonal relations. • Maintain frequent communication with Information Services staff (CSA, CSV, IT), departmental system owners, departmental process owners, and other support functions. • Able to prioritize and operate proactively. • Capable of handling multiple responsibilities and/or projects. • Must exhibit well developed skills in prioritizing, planning, organization, decision making, and time management. • Must demonstrate critical thinking and proven problem-solving skills.
COMPUTER, TECHNOLOGY AND TECHNICAL SKILLS • Advanced proficiency in MS Office, specifically, advanced knowledge of Project, Adobe, OneNote, Excel, Word, and PowerPoint; expert in Outlook. • In-depth understanding of cGMP, 21 CFR Part 11, and related regulations associated with Bio/Pharmaceutical manufacturing and best practices (e.g. ISPE GAMP). • Ability to learn and support new systems and applications, and the ability to provide technical training to end users. • Proficiency or comfort level working with material of a highly technical or scientific nature.
EDUCATION & QUALIFICATIONS • Undergraduate degree in Computer Science, Engineering, Information Systems, Business Systems • Or 10+ years direct, relevant experience in development, delivery, and support of enterprise-wide computerized system solutions to provide a comparable background.
EXPERIENCE PREFERRED: • Minimum of 3-6 years’ experience in one or more of Applications Engineering or Configuration, Application Delivery, Software Development, Data Warehouse Development, Software Requirements Analysis, Information Analysis, or Software/IT Support. • Minimum of 3-6 years’ experience with managing Commercial Off-The-Shelf (COTS) systems or use of programming languages (C, C++, C#, SQL, Python, Java, JS, etc.)
PREFERRED QUALIFICATIONS: • Experience in developing solutions in enterprise class IT systems (i.e. ERP, eQMS, HRIS, SSRS, Qlik, CRM, etc.). • Experience delivering and/or supporting CRM, eCommerce, websites, or content management systems. • Experience working in a highly regulated environment (Pharmaceutical, Medical Devices, Financial). • Experience working per ISPE GAMP 5 best practices and GxP constraints as part of managing Commercial Off-The-Shelf (COTS) systems. • Knowledge of data integrity concerns and regulations. PREFERENCE TO CANDIDATES THAT HAVE BETTER THAN AVERAGE EXPERIENCE ACROSS THESE 3 LAYERS: – Data – Understanding of databases and data models, skilled in writing complex SQL queries – Warehouse – Experience with building, processing, and transforming data with ETL tools (SSIS); data analysis is needed for data modeling and data warehouse architecture. – Reporting – Data analysis, report building with SSRS and Power BI. In general, expecting someone who can dig in and trouble-shoot issues to support the data warehouse and non-manufacturing applications we currently support. Also, as a side note, familiarity with Salesforce platform (related to user Administration) would be a plus.