Why Canton-Potsdam Hospital
FY2024 · Form 990Its mission and biggest programs, as filedProvides skilled, affordable healthcare services and wellness programs to meet the medical needs of residents in the Canton and Potsdam communities.
- Canton Potsdam hospital's mission is to provide skilled, compassionate, cost-effective care that promotes wellness and meets community needs. We strive to improve health, to expand access and lower costs through coordination and integration of services. Our vision is to act…$291.5M spent in FY2024
Before you apply
FY2024 · Form 990Independent: from IRS data, not the orgAbout the role
The org's own posting, as writtenJob Title : Senior CSV/ CSA Specialist Department : Information Technology Location: Remote, East Coast Preferred Hours Per Week: 40 Schedule: Days, Monday – Friday SUMMARY The Lead CSV/CSA Specialist serves as the primary validation lead for complex GxP computerized system projects, overseeing validation planning, execution, documentation, and lifecycle activities. The role partners closely with IT and Quality Assurance, mentors junior team members, and ensures systems comply with internal procedures and regulatory expectations. The position translates CSV/CSA governance requirements into practical, risk-based, and inspection-ready project execution.
RESPONSIBILTIES Validation Leadership and Oversight: Lead validation and assurance planning for assigned new systems, upgrades, integrations, infrastructure changes, software changes, configuration changes, and system retirements, Serve as lead validator or CSV/CSA project lead throughout the system lifecycle and coordinate validation activities across project teams, IT system owners, Quality Assurance, vendors, and business stakeholders, Apply risk-based validation and CSA principles to determine appropriate deliverables, testing rigor, supplier reliance, evidence expectations, and approval strategy.
CSV/CSA Deliverables and Review: Author, review, approve, or oversee validation lifecycle deliverables, including system risk assessments, validation plans or assurance plans, URS, functional/configuration/design specifications, test protocols, traceability matrices, validation summary reports, periodic reviews, and change impact assessments, Ensure documentation is complete, accurate, traceable, reviewable, properly approved, and inspection-ready. Oversee defect management, issue resolution, testing evidence compilation, and validation summary documentation.
Regulatory, Quality, and Audit Support: Ensure assigned systems and changes meet applicable GxP, 21 CFR Part 11, EU Annex 11, GAMP 5, data integrity, electronic records/electronic signatures, internal procedure, and quality expectations, Support internal audits, client audits, supplier audits, regulatory inspections, audit responses, deviations, CAPAs, and remediation plans related to validated computerized systems, Provide SME-level guidance to project teams and stakeholders on validation documentation, evidence expectations, and inspection-readiness practices.
Lifecycle Management and Change Support: Ensure validated systems remain in a state of control through change impact assessments, regression testing, periodic reviews, access/security reviews, backup/restore reviews, data integrity reviews, and lifecycle documentation maintenance, Support proper integration of validation, change control, release readiness, configuration management, supplier management, and SDLC quality expectations, Lead validation impact assessment and test strategy decisions for assigned GxP IT changes. Mentoring and Continuous Improvement: Mentor CSV/CSA Specialists…
About Canton-Potsdam Hospital
From its Form 990- Budget $385.7M · Health Care
- Staff 1,567 · founded 1920
- Pays its leaders $31K–$972K (11 reported)
- Open jobs 300 · Jobs at Canton-Potsdam Hospital · Full 990 report