Validation Specialist job in Nashville, TN
Nashville, TN CorTech LLC
| Job Ref: | 367147 |
| Employer: |
CorTech LLC |
| Job Type: | Contract |
| Salary and Benefits: | 40.76/Per Hour |
| Remote: | No |
Location |
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| City: | Nashville, TN |
| Post Code: | 37203 |
| Map: |
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Description |
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JobsRUs.com. is seeking to hire a Validation Specialist for our client in Nashville, TN! Benefits Available! Weekly Pay! $40.76/Hour Description: Summary: Provide a general overview of the job?s key responsibilities, including responsibility level. Be brief and describe the purpose of the job. Be clear and do not assume the applicant knows the job details or understands abbreviations. The Validation Specialist II provides subject matter expertise on computer system validation and policies at Sarah Cannon Research Institute (SCRI) and Genospace. The Validation Specialist II supports the validation strategy and policies at Sarah Cannon Research Institute (SCRI) and Genospace Works with internal and external customers to ensure compliance with applicable regulations. Helps other Validation Specialists and technical team members to ensure successful delivery of the validated system to meet SCRI business need. Authors computer system validation documentation ensuring compliance with applicable regulations. Duties and Responsibilities: Document the duties and responsibilities that account for at least five percent of the incumbent?s time or are critical to the successful performance of the job. List duties and responsibilities in the order of criticality or those that require the most time. Duties include but are not limited to: Participates on project teams (i.e., business, research applications, developers, IT Infrastructure and Security) throughout the c configuration, testing, and implementation process. Works with development team in translating functional requirements into clearly specified product features. Ensures continued regulatory compliance during software implementation projects and structured development life cycle practices and methodologies. Authors validation deliverables including but not limited to risk/impact assessments, validation plans, requirements traceability, and validation summary reports. Works with Product Analyst/Business Analyst and other VCOE team members in the development of detailed requirements for each new validated system. Works with SCRI developers in the development of a detailed system design for internally developed systems. Develops test strategies and defining test data (i.e., design the approach for testing each requirement) Authors validation testing protocols or scripts (i.e., IQ, OQ, PQ) Coordinates and oversees execution of validation testing protocols or scripts for software being developed internally and/or commercial off the shelf software products including identification and resolution of non-conformances or deviations. Evaluates changes to the validated state of systems and determines validation requirements for applications through change control procedures and participates in the planning and implementation of changes ensures completion of validation documentation before changes are implemented. Tracks and manages change control activities for multiple concurrent projects. Works in a team environment or independently to meet defined objectives based on established timelines and deliver project work in a manner that is consistent with the company?s values. Manages multiple projects with ability to trouble shoot and seek solution. Assists research applications personnel in developing business cases to justify and define new functionality required for new applications. Assists in the selection of and works with research applications personnel and vendors for software installation and implementation. Demonstrates good problem-solving skills, a proactive approach, and a willingness to make decisions, seeking advice when necessary. Assists with the ongoing review of the validation processes ensure processes are continually improved. Perform other duties as assigned. Mandatory: The following are mandatory expectations of all SCRI employees. Practices and adheres to the Code of Conduct philosophy and Mission and Value Statement. During your employment with SCRI, you will be routinely assigned training requirements. You are expected to complete any training assignments by the due date. Competencies: The baseline knowledge, skills, and abilities that are needed to be successful in the position. Knowledge: A body of information needed to perform tasks May be obtained through education, training or experience. Knowledge of FDA GxP requirements for systems, 21 CFR Part 11 and FDA software validation guidelines. Knowledge of EU regulations, e.g., Annex 11 is helpful. Knowledge of industry and international standards for software quality, such as GAMP V, PIC/S, ICH, etc. is helpful. Pharmaceutical, biologics, CRO, and/or medical device industry 21 CFR Part 11 requirements and software validation principles Skills: The proficiency to perform a certain task. Professional demeanor and positive attitude; excellent communication and inter-personal skills. Strong analytical skills, attention to detail, writing and documentation skills and a passion for quality. Abilities: An underlying, enduring trait useful for performing duties. The ability to work as part of a cross-disciplinary team and relate to a diverse number of co-workers. Ability to define, learn, understand, and apply new technologies, methods, and processes. Good time management and organization skills Professional writing and communication skills interpersonal skills Professional demeanor and positive attitude; excellent communication and inter-personal skills. Strong analytical skills, attention to detail, writing and documentation skills and a passion for quality. Minimum Education Required: Bachelor?s Degree | |
ref: (367147)
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