Aditi Consulting · 1 week ago
Specialist Quality Assurance
Aditi Consulting is seeking a Specialist Quality Assurance to provide quality support and oversight for commissioning and qualification processes with a focus on Computer System Validation and Automation support. The role involves collaborating with DTI to ensure quality oversight of technology design and ongoing automation support for manufacturing operations.
AppsConsultingInformation TechnologySoftware Engineering
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 cross-system analysis, feasibility analysis, scope projects, prioritize deliverables, and work together to recommend optimal solutions
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 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
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
Benefits
Medical, dental, and vision benefits
Health savings accounts with qualified medical plan enrollment
10 paid days off
3 days paid bereavement leave
401(k) plan participation with employer match
Life and disability insurance
Commuter benefits
Dependent care flexible spending account
Accident insurance
Critical illness insurance
Hospital indemnity insurance
Accommodations and reimbursement for work travel
Discretionary performance or recognition bonus
Sick leave
Mobile phone reimbursement
Company
Aditi Consulting
Aditi Consulting is a firm that stays abreast of offering technological solutions, project management and digital transformation.
H1B Sponsorship
Aditi Consulting 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 (55)
2024 (44)
2023 (25)
2022 (26)
2021 (24)
2020 (30)
Funding
Current Stage
Late StageRecent News
bloomberglaw.com
2025-10-16
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