GXP CFR IT System Development Lifecycle Administer Training MS Word Excel Organizati   Requirement id 60690 Job title Analyst Job location in Durham, NC Skills required GXP, CFR, Communication Skills, IT System Development Lifecycle Administ Open Date 03-May-2017 Close Date Job type Contract Duration 12 Months Compensation DOE Status requirement --- Job interview type ---    Email Recruiter: coolsoft Job Description Analyst: GXP, CFR, Communication Skills, IT System Development Lifecycle Administ Start Date : 05/15/2017 End Date : 05/18/2018 Submission Dead Line : 05/09/2017 Description : Sr IT Analyst, Regulatory Compliance BIIBJP00008857 Description The IT Analyst supports the IT Quality & Regulatory Compliance operation, team members and major system development life cycle activities, including validation review and change control approval of IT systems. Reports to: Wendy Zambrana, Associate Director of IT Quality & Regulatory Compliance II. 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. Assist in the development of IT Controls. Support administration of IT training records database III. JOB DEMANDS: This job requires the IT Analyst to attend department and project meetings, administer essential tasks related to IT Training, and other ITQ processes. The IT Analyst must maintain a professional manner in representing ITQ and in working with its customers and associates. The IT 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. IV. JOB IMPACT: The IT Analyst role provides a valuable service to ITQ, IT and Biogen in maintaining procedures and systems that are compliant with both regulatory (e.g., FDA) and corporate requirements and good business practices. IV. QUALIFICATIONS: Knowledge of GxP and ERES (21 CFR Part 11 and Annex 11) regulations and guidelines Excellent communication skills, both verbal and written 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 Experience with training records and document management systems The ability to work both independently and with teams at various levels in the organization Excellent organizational skills and attention to detail and accuracy Three or more years of experience in computerized system validation within a regulated environment Note: This description is not intended to be all-inclusive or a limitation of the duties of the position. It is intended to describe the general nature of the job that may include other duties as assumed or assigned. Expense Budget ID NA   Call 502-379-4456 Ext 100 for more details. Please provide Requirement id: 60690 while calling.   Other jobs in NC: Chapel Hill (2), Charlotte (58), Dix Campus (1), Greensboro (3), Morrisville (2), North Charlotte (2), Raleigh (96), St Raleigh (2), Winston Salem (3),    GXP job openings in other states Jobs List Sr. IT PM- ETMF - 39271 Create date: 09-Oct-2018 Candidate must be our own W2 Employee Job Description : eTMF Project Manager Opportunity - Cambridge, MA Apex Systems combines with parent company On Assignment (NYSE: ASGN) to make it the 2nd largest IT staffing agency in the country. Apex has an opportunity for an eTMF Project Manager for a client in C.... 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