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Sr Business Systems Analyst

Covance 4/3/2019 6:12:57 PM
JOB ID: 29815 Category: Information Technology
Indianapolis, Indiana

   

 

Job Overview

As a part of the Xcellerate Labs team focused on Covance's Clinical Trials Testing Solutions (CTTS) business unit, the Sr Business Systems Analyst will participate in ongoing and future initiatives related to pre-project research and analysis, requirements elicitation, guiding software validation initiatives, and documentation. The selected candidate will be responsible for updating and maintaining documentation to be compliant with the Work Instructions (WIs), Standard Operating Procedures (SOPs) and regulatory agency guidelines. This role will work across IT and various business units to bring a common mindset for software implementation and identifying future goals. This role will work with system stakeholders, including internal users, customers, and investigators to ensure that our platforms provide an outstanding user Experience .

Other responsibilities include:

* Leveraging technology to help reduce manual tasks and continually improve on the company's requirements process.
* Defining, reviewing, executing, and ensuring compliance with policies, standards, and procedures related to Computer Systems Validation (CSV) and qualification of infrastructure components.
* Coordinating project-specific CSV efforts, including assistance with coordinating execution of the test plan, assembling testing results into a validation package, and addressing concerns and findings raised by quality assurance personnel.

Education/Qualifications

Bachelor's degree in science, engineering, computer science, or similar field.

Experience

Minimum Required

* 4+ years' Experience in life sciences industry.
* Awareness of software development lifecycle concepts.
* Demonstrated Experience in working with customers, identifying/understanding their needs, and formally documenting business requirements.
* Proven familiarity with FDA GxP and 21 CFR Part 11 regulations.
* Proven familiarity with computer system validation concepts and their implementation in an IT organization.

Preferred

* Experience in FDA (GXP) regulated industry (such as pharmaceutical, CRO, medical device, biotechnology or related industry).
* Ability to manage multiple priorities and work with distributed teams.
* Experience with business process modeling and requirements management tools (Jama, JIRA, Visio, HP ALM, and TopTeam).
* Self-management and organizational skills.
* Good verbal, written, presentation, interpersonal skills.


Position Type: Full-Time

Location: Indianapolis, IN - Indiana



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Covance Recruiting Process

Below is a general Overview of Our Recruiting Process

If you’d like to work for us, please submit your resume/CV online. If your ability to use or access our electronic application is limited due to a disability, please visit www.gettinghired.com or call 1-800-978-4473 for help.

We consider applications from everyone who is interested in a position with us and who meets the required criteria and qualifications.

If your application is selected, someone from our recruiting team will contact you to arrange an initial screen. We may carry this out over the phone or at a face-to-face meeting. You must complete the screen to be considered for the position.

Based on the results of the initial screen, we may invite you to an interview. One of our recruiting team members will contact you to arrange this. The process may involve several interviews, initially over the phone, and then face-to-face with different members of the hiring team.

Our interviews follow a behavioral-based format. This means we’ll ask you to give us information that’s specific to your professional and educational experiences.

Hiring team members will share and discuss their input and then make their decision.

If you’re the person who best meets the requirements of the position, a member of the hiring team will get in touch to make you an offer of employment. Covance is an eVerify employer (United States only).