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System Validation/Compliance Analyst job in Fairport, NY 14450

We are currently recruiting on a System Validation/Compliance Analyst job in Fairport, NY 14450.
In this role, you will be responsible for supporting, testing and validation activities for enterprise information systems.
Primary responsibilities include maintenance of validated state of computer system environments, and supporting implementation of new systems.
Essential Functions of this System Validation/Compliance Analyst job in Fairport, NY 14450 include, but are not limited to:
o Writes and reviews computer system validation documentation including Validation Plans, CSV risk assessments, test plans, test summary reports, test scripts, data migration plans/reports, Traceability Matrix and Validation Summary Reportso Provides guidance in development of corporate standards, policies and standard operating procedures (SOPs) for Information Systemso Works closely with other compliance analysts and internal audit on harmonizing control requirements and frameworks Assists as subject matter expert in the implementation of computer system validation processes and procedureso Trains and mentors others in computer system life cycle methodology o Provides guidance with functional/ end user requirements, compliance and interface specifications, and ensures that proper documentation is maintained.
o Provides guidance in planning, implementing, and documenting user acceptance testing.
o Provides test execution training and assists teams with the discrepancy management o Analyzes formal test results in order to identify weaknesses/failures in control performance and documentation.
Reports to management on trends, identified weaknesses and identifies corrective action plans for remediation.
o Ensures compliance with internal and external computer system life cycle policies and regulations.
o Supports Regulatory inspections and internal and partner audits, and implements corrective actions as needed.
Provides CSV related responses to inspectors/auditorso Performs periodic reviews and remediation activities on validated systemso Oversees small projects and/or tasks and phases of larger projects.
You will be responsible for coordinating activities of teams, schedules and resources for assigned tasks or projects.
o Maintains current system inventory listsQualifications for this System Validation/Compliance Analyst job in Fairport, NY 14450 include, but are not limited to:
o Deep experience in Software Quality Assurance and Computer System Validation and Requirements Analysis.
o Familiar with Systems Delivery/Development Life cycle Management (SDLC) and Change Management methodologies and frameworks.
o Knowledge of Regulatory Procedures ISO3485, FDA 21 CFR Part 11 and Part 820 with good understanding of GxP related processes including Risk Based validationo Ability to engage, interact, and negotiate effectively with IT, QA, validation and business project team members.
o Prior exposure to manufacturing, supply chain and logistics operations would be beneficial.
o Exposure to and able to develop dashboards from BI tools.
o Knowledge of the business enterprise functions and processes.
o Good analytical and problem solving skillso Ability to adapt to a fast and dynamic environment.
o Ability to effectively translate between functional and technical teamso Ability to follow procedures and produce/maintain supporting documentation.
o Excellent written, oral, and interpersonal communication skills.
o Excellent time managemento Highly self-motivated, self-directed, and attentive to detail.
o Extensive experience working in a team-oriented, collaborative environmento Although not essential prior exposure to Oracle E business suite would be extremely useful.
o Ability to communicate effectively with senior managemento Adapts readily to changes in workload, staffing and scheduling.
o Complies with all company policies and procedures.
Experience:
o 5 to 8 years' experience in assigned function's business process and supporting systems.
o Commensurate Technical experience to perform the job duties.
o Must be proficient with Microsoft OfficeEducation:
o Bachelors of Science Degree in relevant field or equivalent experience is required If you are interested in this System Validation/Compliance Analyst job in Fairport, NY 14450, please apply.


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