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GxP Systems Validation Analyst

Company: ImprimisRx
Location: Ledgewood
Posted on: January 15, 2022

Job Description:

At ImprimisRx we are working hard to help our customers navigate the realities of the healthcare market by providing innovative medications that address both clinical and economic needs. To get there, we need exceptionally talented, bright, and driven people. If you would like to help us build a quality culture organization trusted by healthcare professionals from across the US, this is your chance to join us. We are looking for a dynamic, organized self-starter to lead our systems validation efforts.
Job SummaryReporting to the Sr. Director of IT, the GxP Systems Validation Analyst is primarily responsible for managing IT computer system validation (CSV) efforts related to warehouse management systems, document management systems and quality management systems. Oversee project management related to both validation migration of existing systems and implementation. Provide subject matter expertise in development of validation requirements and overall IT execution. Manage IT aspects of testing, training, implementation, and support of system validation requirements. The position is based in Ledgewood, NJ location. You will collaborate with functional departments to empower efficiencies and cost saving measures.Essential Duties & Responsibilities

  • Work together with Operations, Quality, IT teams supporting all phases of CSV solutions for new or existing systems
  • Ensure that all appropriate tools/processes are leveraged, effectively communicated, and supported throughout the CSV process
  • Ensure all CSV documentation is completed timely and in accordance with Current Good Manufacturing Practices (CGMPs)
  • Assist with analysis of operational requirements and solution design
  • Drive the development of test plans, data, and cycles to ensure that all validation requirements are satisfied
  • Review of corporate software documentation for adherence to product integrity/configurability and functional requirements
  • Other duties as assigned related to special projects
    Knowledge, Skills & Abilities
    • Bachelor's degree preferably in Logistics, Supply Chain Management, or Computer System Validation
    • Minimum 4 years technical experience working with FDA regulated products including warehouse management systems, order management systems and/or enterprise application integration tools
    • Minimum 3 years of computer system validation experience
    • Good interpersonal, written, and oral communications skills
    • Ability to manage multiple tasks and prioritize workload to meet deadlines and able to work with minimum supervision
    • Attention to detailPhysical DemandsThese physical demands are representative of the physical requirements necessary for an employee to successfully perform the essential functions of the job. Reasonable accommodation can be made to enable people with disabilities to perform the described essential functions.Essential functions of this role require walking, standing, and sitting for extended periods of time. This role requires the ability to talk, hear, write, read, type, and use a computer to research information. The employee filling this position may occasionally be required to lift and/or move up to 50 pounds. Specific vision abilities for this job include close vision, depth perception and ability to adjust focus. Less than 5% travel is required for this position.Work EnvironmentWhile performing the responsibilities of the job, these work environment characteristics are representative of the environment the job holder will encounter. Reasonable accommodations may be made to enable people with disabilities to perform the essential functions of the job.This role is in an office environment with exposure to computer screens, noise, telephone use and electrical energy. The role has extensive contact with internal staff, external staff, physicians, pharmacy staff and patients.AAP/EEO StatementImprimisRx believes in creating long-term relationships by being responsive and relevant and by consistently delivering value to our community of customers. Specifically with our employees, we focus on attracting, developing, and retaining the best talent for our business, challenging our people, demonstrating a "can-do" attitude and fostering a collaborative and mutually supportive environment.Diversity creates a healthier atmosphere: All qualified applicants will receive consideration for employment without regard to age, ancestry, race, color, religion, sex, national origin, protected veteran status, disability status, marital status, medical condition, genetic information, national origin, gender (including gender identity and expression), or sexual orientation. ImprimisRx is a drug-free workplace. Candidates are required to pass a drug test before beginning employment. In addition, employees in certain positions are subject to random drug testing.Other DutiesPlease note this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. Duties, responsibilities, and activities may change at any time, with or without notice.

Keywords: ImprimisRx, Newark , GxP Systems Validation Analyst, Professions , Ledgewood, New Jersey

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