Posted Friday, January 26, 2024 at 5:00 AM
ROLE SUMMARY
Provides senior IT business analysis services for enterprise software applications within the IT Quality and Manufacturing team. Also assumes overall management of select applications including licensing, request intake, and customer relationships. All work will be conducted according to both established standards and policies as well as identifying and building these standards and practices. This is an additional role that will support a global customer base and includes periodic travel to sites in the US and UK.
ROLE RESPONSIBILITIES
Partner with customers and key stakeholders to understand requirements for systems and ensure systems, and enhancements, meet these needs.
Support various off-the-shelf software applications including Trackwise, MasterControl, and EMAS Global.
Ensure high customer satisfaction for owned IT systems and services.
Participation in all phases of the Systems Development Lifecycle including planning, requirements determination, current state analysis, solution design, estimating, construction, testing, training, implementing, and ongoing support and improvement.
Establish ongoing service & support plans and models with related proposed structure, SLA's and KPI's for solutions.
Liaison with others on IT team for technical resources and vendor support teams.
Coordinate work with vendors and guide contractor work.
Contribute to, and apply, Kindeva IT methodology, procedures, and tools.
Contribute validation expertise to systems and initiatives.
Perform fit-gap analysis (tradeoffs) for off-the-shelf software configuration to match business functional requirements.
Develop workable resource, costs, and duration or effort-based estimations; build functional project plans with peer team members.
Identify key testing areas and simplified testing strategies based on FMEA - working closely with peer technical teams and business customers.
Managing, coordinating vendor resources from sales/business development through solution implementation.
Review and confirm RFP / SOW details to ensure correct services or project scope for outsourced efforts – verifying deliverables within execution.
BASIC QUALIFICATIONS
A bachelor's degree in Computer Science (or equivalent education and work experience).
7+ years experience as IT Business Analyst or Solution Analyst.
Strong working knowledge of IT best practices, tools, and system development lifecycle.
Proficient with general office productivity tools including the MS Office suite.
Experience and expertise with quality and manufacturing software; a plus for specific knowledge of Trackwise or MasterControl.
Strong working knowledge, and 3+ years of experience, with software validation and FDA 21 CFR regulations.
Certification IIAB or PM-PBA; willingness to obtain in first 12 months.
Expert use of tools such as Excel, PPT, Visio to build analysis and workflow modeling.
Demonstrated mastery of requirements writing and risk analysis.
Well versed in one or more industry standard change-management methodologies (eg. ADKAR, Prosci, Kotter).
Basic SQL skills to interrogate and format data outputs for business analysis.
Solid understanding of IT architecture – tier models, Web applications and architecture patterns, and network topology.
Strong knowledge of Windows OS and Microsoft based user security models.
Excellent status report and PPT presentation presenting to business customers and IT management.
Experience with common industry Quality and Manufacturing related IT solutions (eg MES, QMS, IOT, EBR, Barcode labeling systems, tablet computing, Data Historian, ERP).
Kindeva Drug Delivery (KDD)/Meridian Medical Technologies (MMT) is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status. KDD/MMT also complies with all applicable national, state and local laws governing nondiscrimination in employment as well as work authorization and employment eligibility verification requirements of the Immigration and Nationality Act and IRCA.
Safety for our employees and our communities is a key priority for Kindeva Drug Delivery. Kindeva encourages everyone who can get vaccinated to get vaccinated.
Our Covid-19 task force monitors the external environment and will continue to evaluate our policies and procedures.
Equal Opportunity Employer:
Kindeva Drug Delivery is an Equal Opportunity/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, gender, age, national origin, disability, Protected Veteran status, sexual orientation, or any other characteristic protected by federal, state or local law.
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