| Quality Systems Specialist with Veeva, biotech and Microsoft suite || Hybrid and local only to Waltham, MA at Waltham, Massachusetts, USA |
| Email: [email protected] |
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http://bit.ly/4ey8w48 https://jobs.nvoids.com/job_details.jsp?id=1857910&uid= From: Akhilesh, DMS VISIONS [email protected] Reply to: [email protected] Hi, Hope you are doing well, This is a contract position, Please share with me Updated resume of yours or your consultant if the profile matches this requirement. Quality Systems Specialist Rate- $40/hr C2C, max Visa Open Hybrid role in Waltham, MA ( Local only) Duration 5 months (with extension possible) Must Have vs. Plus 2-3 years exp. In biotech or regulated industry (required) 2-3 years exp. Microsoft Suite (required) 2-3 years exp. Veeva or ComplianceWire admin (Highly desired) Job description KEY AREAS OF JOB ACCOUNTABILITY:(list of key objectives and quantifying standards) The Quality System Specialist, under the direction of the QS&C management team, will be responsible to support the global Quality Systems and their operations in ensuring compliance and fit for intended use in accordance with applicable global SOPs. Position details: Assist in governance of Quality System applications, including harmonization of processes across sites Assist in gathering requirements for improvements and ongoing maintenance by participating in meeting/workshops with Site Process Owners and business SMEs Participate in additional user forums for gathering ongoing requirements and prioritization and triage issues Follow-up on requests, issues, and projects and report statuses to manager/ working teams Initiate and manage change controls, with associated documentation requirements, to completion Ensure system is maintained in a validated state by participating in periodic user access review, ongoing change management, business administration, and deviations/CAPAs associated with Quality Systems Support investigation, escalation, and resolution of issues identified on the system Support validation activities as requested; this includes but is not limited requirements gathering, validation planning, design qualification, authoring test plans and test scripts, execution of test scripts, discrepancy management, and authoring system description and validation summary reports Support manager with ongoing communication from vendor/IT where required Provide customer support through system and training management and onboarding of new users Generate metrics to support quality systems Support regular system updates/ releases and provide assessment of and recommendations regarding new features Maintain key user-related documentation and ensure it is kept up-to-date as new functionalities are enabled, created and/or modified ACADEMIC/TECHNICAL QUALIFICATIONS: Bachelors degree or higher in relevant computer/technical/quality/scientific discipline, preferably multi-disciplinary with a strong technical and quality background Minimum of 3-6 years of experience in a high volume commercial / clinical pharma / healthcare facility Proficient in MS Word, Excel, and Quality System processes. Experience with Veeva Vault Quality Docs, TrackWise, and ComplianceWire is a plus. Understanding and working knowledge of US FDA and European regulatory requirements and GAMP, andthe ability to determine phase appropriate requirements Knowledge of Regulatory Compliance and ICH Guidelines Thank you [email protected] Direct :- 972-645-0322, Ext :- 110 DMS Visions, INC Keywords: cprogramm information technology microsoft Massachusetts Quality Systems Specialist with Veeva, biotech and Microsoft suite || Hybrid and local only to Waltham, MA [email protected] http://bit.ly/4ey8w48 https://jobs.nvoids.com/job_details.jsp?id=1857910&uid= |
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| 01:26 AM 19-Oct-24 |