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Software Validation Specialist at CooperVision, Inc

Posted in Information Technology 30+ days ago.

Type: Full-Time
Location: Rochester, New York





Job Description:

CooperVision, a division of CooperCompanies (NYSE:COO), is one of the world’s leading manufacturers of soft contact lenses. The Company produces a full array of daily disposable, two-week and monthly contact lenses, all featuring advanced materials and optics. CooperVision has a strong heritage of solving the toughest vision challenges such as astigmatism, presbyopia and childhood myopia; and offers the most complete collection of spherical, toric and multifocal products available. Through a combination of innovative products and focused practitioner support, the company brings a refreshing perspective to the marketplace, creating real advantages for customers and wearers. For more information, visit www.coopervision.com

Job Summary:

Responsible for testing and validation activities for enterprise information systems. Primary responsibilities include maintenance of validated state of CooperVision computer system environments and supporting implementation of new systems.

Essential Functions & Accountabilities:


  • Writes and reviews computer system validation documentation including computer systems validation (CSV) plans, risk assessments, test scripts, data migration plans/reports, traceability matrix and summary reports

  • Provides input to development of corporate standards, policies and standard operating procedures (SOPs) for Information Systems

  • Works closely with other compliance analysts and internal audit on harmonizing control requirements and frameworks

  • Trains and mentors project team personnel (developers, testers, business systems analysts) at company level in computer system lifecycle methodology  

  • Provides guidance with functional/ end user requirements, compliance and system specifications, and ensures that proper documentation is maintained

  • Provides guidance in planning, implementing, and documenting user acceptance testing

  • Provides test execution training and assists teams with the discrepancy management

  • Analyzes formal test results in order to identify weaknesses/failures in control performance and documentation

  • Reviews requirements traceability matrices for completeness of appropriate documentation and testing for user specific requirements

  • Ensures compliance with internal and external computer system lifecycle policies and regulations

  • Performs periodic reviews and remediation activities on validated systems

  • Oversees small projects and/or tasks and phases of larger projects. Responsible for coordinating activities of teams, schedules and resources for assigned tasks or projects

  • Maintains current system inventory listing

  • Interacts with auditors (FDA, SOX) to provide necessary documentation

Travel Requirements:

Up to 5% travel per annum

Qualifications

Knowledge, Skills and Abilities:


  • Experience in Software Quality Assurance and Computer System Validation and Requirements Analysis.

  • Familiar with Systems Delivery/Development Lifecycle Management (SDLC) and Change Management methodologies and frameworks.

  • Knowledge of Regulatory Procedures FDA 21 CFR Part 11, Part 820, SOX and ISO3485 with good understanding of GxP related processes including risk based approach and validation

  • Adherence to IS policies and procedures to ensure quality of service and compliance with regulatory requirements

  • Ability to engage, interact, and negotiate effectively with IT, QA, validation and business project team members.

  • Prior exposure to manufacturing, supply chain and logistics operations would be beneficial.

  • Knowledge of the business enterprise functions and processes.

  • Good analytical and problem solving skills

  • Ability to adapt to a fast and dynamic environment.

  • Ability to effectively translate between functional and technical teams

  • Ability to follow procedures and produce/maintain supporting documentation

  • Excellent written, oral, and interpersonal communication skills

  • Excellent time management

  • Highly self-motivated, self-directed, and attentive to detail

  • Extensive experience working in a team-oriented, collaborative environment

  • Ability to communicate effectively with management

  • Adapts readily to changes in workload, staffing and scheduling

Work Environment:


  • Normal office environment

  • Sedentary to light physical effort necessary to perform the job

  • Extensive contact with employees and external business partners and vendors

Occasional travel, off-hour meetings, weekends

Experience:


  • 1 to 3 years’ experience in assigned function’s business process and supporting systems

  • Commensurate Technical experience to perform the job duties

  • Must be proficient with Microsoft Office and Adobe Acrobat

  • Experience with automated systems for following activities/functions is helpful:

    • Enterprise Resource Planning (Oracle E Business Suite)

    • Document management (Oracle Agile/Sharepoint)

    • Requirements and Testing (HP ALM/HPQC/JIRA)

    • Change/Incident Management (ServiceNow/Remedy)

    • Project/Task Management (Innotas/Microsoft project)



Education:


  • Bachelors of Science Degree in relevant field required; or an equivalent combination of education and experience is required

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