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QC APPS Lab Systems Manager Position

Company: Urpan Technologies, Inc.
Location: Novato
Posted on: June 21, 2020

Job Description:

We at Xcel Life Sciences are looking for Lab Systems Manager for our client in Novato, CA. If interested, please reply back with your updated word format resume. SUMMARY The GxP Laboratory Instruments Manager in the Information Management department will provide the application and implementation support for GxP laboratory instruments. The GxP Laboratory Instruments Manager will ensure that systems are implemented efficiently following a standard process so labs are delivered systems that enhance compliance, improve efficiency, reduce regulatory risk, and meets the expectations of the key business stakeholders. RESPONSIBILITIES Coordinate projects and manage deliverables across multiple departments (QA, QC, IM etc.). Organize project meetings and perform standard meeting organizer duties (agenda, minutes action items etc.) Research systemsoftware functionality for COTS systems to determine suitability and capability of meeting user requirements Configure software using the standard lsquoout of the boxrsquo interface Draft SDLC documents including FRS, CS, UAT and Test Cases Draft SOPs, work instructions, and other training materials Document and communicate project outcomes (PositiveNegative) to management and participate in efforts to improve the process Educate System Owner regarding compliant software and business process choices that ensure data integrity is maintained Assist in ad-hoc projects as needed to address deviation investigations or initiatives Perform Post-Go live systemapplication support Defend systems as SME during audits SKILLSEXPERIENCE Required Ability to plan and prioritize assignments effectively to meet timeline commitments 8 years in a regulated industry (preferably PharmaceuticalBiotech, Medical Devices or Healthcare industries) Strong interpersonal communication skills including, formal presentations, meeting management, negotiationpersuasion and conflict resolution Self-motivation, and be a quick learner of business processes and technology Managing Personnel for performance. Desired Experience implementing, administering, or supporting common software solutions used in a GxP lab (SoftMax Pro, Empower, WinKQCL, etc.) 2 years bench level laboratory experience 5 years direct experience implementingvalidating software in a regulated environment Experience leading Risk Assessment activities and mitigating data integrity vulnerabilities Experience as a Project Manager or Project coordinator with knowledge of Agile, SCRUM, and traditional Project Management methodologies Experience in generating SDLC deliverables particularly URS, FRS and Config Spec ExperienceKnowledge of good requirements gathering techniques including process mapping techniques. (LEAN, SIX SIGMA) Experience in standard software development methodologies (Rapid, Waterfall, etc.) Experience initiating and managing Change Control, and Deviations requests with TrackWise Experience with HP ALM or equivalent software testingrequirements tools ASQ, PMI, ITIL certifications Thanks and Regards, Chuck Account Manager Mail C 408 600 0528

Keywords: Urpan Technologies, Inc., Novato , QC APPS Lab Systems Manager Position, Executive , Novato, California

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