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- Analyst
(Jobs in Raleigh, NC)
 
Requirement id 75081
Job title Analyst
Job location in Raleigh, NC
Skills required Excel, Risk Assessment, -,
Open Date 05-Nov-2018
Close Date
Job type Contract
Duration 6 Months
Compensation DOE
Status requirement ---
Job interview type Face to Face interview
   Email Recruiter: coolsoft
Job Description Analyst: Excel, Risk Assessment, -,

Candidate must be our own W2 Employee

Job Description :


Position: IT Quality Analyst

Position Description:

The IT Quality Analyst supports the IT Quality department, team members and system development life cycle activities, including validation review and change control approval of IT systems



PRINCIPAL DUTIES & RESPONSIBILITIES:

Administer ITQ processes, manage team meetings and action register •
Support ITQ team in the review of system life cycle deliverables and activities that ensure regulations, protocols, procedures, and methodologies are followed, and that appropriate and complete documentation is captured and reported to support validation activities.



JOB DEMANDS:

This job requires the IT Analyst to attend department and project meetings, administer essential tasks related to ITQ processes. The ITQ Analyst must maintain a professional manner in representing ITQ and in working with its customers and associates. The ITQ Analyst should demonstrate initiative and self-direction while also knowing when to seek assistance. This person must also be able to routinely schedule and complete multiple tasks and be timeline driven.



JOB IMPACT:

The ITQ Analyst role provides a valuable service to ITQ, IT and Biogen in maintaining SDLC deliverables and systems that are compliant with both regulatory (e.g., FDA) and corporate requirements and good business practices.


QUALIFICATIONS:

Knowledge of GxP and ERES (21 CFR Part 11 and Annex 11) regulations and guidelines
Experience performing Risk Assessments
Experience on Risk based validation approach
Experience validating SAAS solutions
Excellent communication skills, both verbal and written
Detailed knowledge on Data Integrity Requirements
Detailed knowledge of the IT system development life cycle and software quality assurance in a regulated environment
Experience administering processes, scheduling and managing team meetings, and following up on action items
Experience with MS Word, Excel, Outlook and other business software programs
The ability to work both independently and with teams at various levels in the organization
Excellent organizational skills and attention to detail and accuracy
Seven or more years of experience in computerized system validation within a regulated environment
Experience working with ALM (HP), preferred.


Requirements:

Bachelors or Masters degree in Life Sciences or Software Engineering
 
Call 502-379-4456 Ext 100 for more details. Please provide Requirement id: 75081 while calling.
 
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(Analyst: Excel, Risk Assessment, -, in Raleigh, NC)
     
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