Infotree Global Solutions ยท 13 hours ago
Quality Assurance Specialist (CSV)
Holly Springs, NC
Contract
Onsite
Mid, Senior Level
3+ years expInfotree Global Solutions is seeking a Quality Assurance Specialist to provide quality support and oversight for commissioning, qualification, and process qualification with a focus on Computer System Validation. The role involves collaborating with Digital, Technology and Innovation teams to ensure QA oversight for various automation projects and managing relationships with service and system owners.
Human ResourcesStaffing AgencyTechnical Support
Hiring Manager
Abhey Abrol
Responsibilities
Support the Quality oversight associated with Commissioning & Qualification (C&Q) and validation activities for site. These activities will involve facilities/utilities, equipment/systems, computerized systems, process and validation maintenance, with an emphasis on Computer Systems Validation (CSV)
Work to be the QA partner on a varied portfolio of DTI and automation platforms projects with appropriate portfolio planning, resource, risk management and QA oversight
Support DTI in the cross-system analysis, feasibility analysis, scope projects, prioritize deliverables, and work together to recommend optimal solution
Effectively manage relationships with DTI service and system owners, business partners, enterprise DTI service partners, and vendors
Provide QA support for managing DTI platform activities including system administration, troubleshooting, vendor management, platform lifecycle and business requirements
Responsible for reviewing and approving qualification protocols, reports, risk assessments, technical studies, and any associated documentation in support of CSV computer systems validation
May include providing QA Oversite for Kneat protocols, Quality approval of ALM test scripts, approval of Service Now work requests, and QA approval of Maximo Work Orders
Provide quality guidance and support during execution of commissioning and qualification testing, reviewing, and approving changes and discrepancies, as required
Ensure that all activities & related documentation for facilities, equipment, materials, computer systems and processes comply with applicable regulations and Client requirements relating to Good Manufacturing Practices, Good Documentation Practices, Safety, and Controls
Provide timely feedback and collaborate with authors and engineers to address document gaps or discrepancies
Participate in meetings related to document planning, execution, and issue resolution
Escalate any compliance concerns or critical gaps to QA management
In line with business requirements, these responsibilities may expand or otherwise include additional areas of responsibility which are not described in this specification but are associated with the role
Qualification
Required
Doctorate degree OR Master degree and 3 years of experience OR Bachelor degree and 5 years of experience OR Associate degree and 10 years of experience OR High school diploma / GED and 12 years of experience
Previous experience in computer system validation (CSV) or quality oversight of CSV
Experience with computerized systems including troubleshooting, reliability, and performance improvements
Preferred
Experience with the following product platforms: Data Historian (OSI PI), MES (Korber), Delta V Automation platform, and/or laboratory systems and/or IS platforms, highly desired
Company
Infotree Global Solutions
Infotree Global Solutions is a talent management company specializing in staffing and payroll solutions.
1001-5000 employees
H1B Sponsorship
Infotree Global Solutions has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (8)
2024 (9)
2023 (11)
2022 (17)
2021 (16)
2020 (19)
Funding
Current Stage
Late StageTotal Funding
unknownKey Investors
Kingswood Capital Management
2025-02-20Private Equity
Leadership Team
Matt Milano
Chief Executive Officer
Klaus Geiser
Chief Financial Officer
Recent News
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