| Local to WI || Validation Analyst || No H1B & CPT at Remote, Remote, USA |
| Email: [email protected] |
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Attach DL of WI Validation Analyst Location: working in Middleton, WI. Rate: $52/hr c2c. Visa: No H1B and CPT Please provide me with two prior work references with work email and work phone number. I WILL BE CHECKING THEM PRIOR TO SUBMISSION. Must Have: Experience validating software for laboratory equipment o Ex) Empower, Chromeleon, SDS (Sequence Detection Software), 32 Karat Provides basic business/system support of software systems and/or laboratory instrumentation. Works with staff of various departments and the client to initiate and complete performance qualification (PQ) validation. Facilitates the validation process and implementation of system upgrades, including guiding, testing, supporting the introduction and ongoing support of software systems. Essential Functions Participates as a validation representative at project team meetings and completes assigned action items. Provides direction for future releases to software systems; reviews and approves/rejects change requests. Communicates proactively with all project team members and provides regular feedback to management concerning timeline/budget or resource constraints. Provides validation support for new releases and modifications to applications throughout the software development life cycle. Prepares validation plans, test cases and validation summary reports, and executes test cases. Reviews and approves all change controls associated with validated systems per SOP. Reviews PQ and change control documentation with leadership per SOP. Ensures test scripts challenge the functional requirements and adequately demonstrate that the application meets the expectations of the business customer. Executes test scripts accurately to produce evidence that the computer system consistently performs its intended functions accurately and reliably, proving the software functions correctly. Creates, updates, and manages sufficient data within the testing environment to accurately test software functionality. Works with leadership to address any PQ related issues arising from client or internal audits. Manages assignments to meet deadlines and produce high quality deliverables. Remains familiar with relevant contractual obligations, sponsor expectations, applicable regulations, and SOPs. Participates in the identification of user requirements and system design and assists in the preparation and review of system documentation such as requirements and design specifications for software systems and/or instrumentation. Education and Experience: Bachelor's degree or equivalent and relevant formal academic / vocational qualification Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 2+ years). Demonstrated competency with Microsoft Office Suite (Word, Excel, PowerPoint, and Project). Proven ability to learn new computer software with minimum of instruction Solid understanding of clinical trials operational processes and terminology and solid understanding of the software development life cycle (SDLC) Strong troubleshooting skills and ability to analyze software defects, assess the cause of test failures, and explain how errors are produced Ability to attain, maintain, and apply a working knowledge of GCPs, applicable SOPs/WPDs, and process maps Ability to review and critique SDLC documentation including requirements, functional design, system design, and test plans. Ability to assess the cause of test failures Demonstrated ability to coordinate project activities and work and communicate effectively on a multi-disciplinary team Regards, Steve Williams Technical Recruiter P : +1 (908) 449 3004 A : 25 Oak Tavern Cir Branchburg, New Jersey - 08876 Email Disclaimer: This email and any attachments are confidential and intended solely for the recipient. If you received it by mistake, please notify the sender and delete it. The views expressed are solely those of the sender and not necessarily those of the company. We do not accept responsibility for any viruses transmitted. Email communication may be monitored. Click Here to -- Keywords: information technology Wisconsin Local to WI || Validation Analyst || No H1B & CPT [email protected] |
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| 12:53 AM 13-Nov-24 |