Sr.Validation tester

Location: Rockville, ND
Date Posted: 09-30-2018
Must Haves:
• Experience with validation systems critical
• IQ, PQ, OQ
• GxP Principles
• 21 CFR Pt 11

Job Description:
• Responsibilities include (but are not limited to) coordination of computerized system validation activities, testing and evaluation of software programs against design specifications and user requirements, and serves as the liaison between the appropriate IT teams, the operational business units and external partners (where applicable) to ensure project expectations are properly set and met.
• Utilizes requirements traceability and risk based approaches for all development projects, and participates in requirements planning, design and execution, User Acceptance Testing activities, defect management, results analysis and presents findings for Go/No Go meetings.
• Responsible for a combination of individual contributions and oversight of a third-party service provider (as applicable) when executing primary duties and responsibilities.
• Responsible for identifying adequate level of Quality Assurance oversight on various IT and computerized systems.
• Coordinates with the appropriate IT teams and/or third-party vendors in the preparation, development, maintenance and execution of a wide range of complex quality test plans, test cases, and test scripts with full competency of the Software Testing Lifecycle, as part of the SDLC, to ensure software meets or exceeds specified standards and end user requirements.
• Performs third party oversight and/or individual detailed risk assessments and drafts or revises test plans and scripts to support solutions; documents discrepancies and works with other technical associates on the resolution of the discrepancies.
• Supports specialized testing as needed including security testing, environment readiness, batch schedule validation, performance and automated testing On a limited basis may assist teams in all functional testing types including functional, regression, systems and integration testing.
• Conducts QA audits throughout project life cycle.
• These activities include review of design documents through review of testing results and associated defect records. Participate in the creation and maintenance of documentation to support processes and/or applications. Responsible for ensuring completeness and adherence to Standard Operating Procedures (SOP) and provides guidance on creation of those SOPs.
• Coordinate with IT, QA and applicable business unit management in the training on testing policies, practices and tools to project team members. This may consist of informal activities such as on-on-one training up through formal preparation of training materials and class room training.
• Facilitates User Acceptance Testing activities and assists in the third-party oversight and/or individual maintenance of test plans to assigned products to assure product quality from a functional and qualitative perspective.
• Provides coaching and advice on best practices surrounding Quality Assurance initiatives and acts as an ambassador of Quality. Complies with all appropriate policies, procedures and safety rules and regulations. Travels up to 15% of the time. Performs related duties as assigned.
• Requires some training in fields such as business Administration, accountancy, sales, marketing, computer sciences or similar vocations generally obtained through completion of a four-year Bachelor’s Degree program, technical vocational training, or equivalent combination of experience and education Experience in validation of GxP systems.
• Experience in auditing of IT and validated systems.
• Experience in creation and review of Standard Operating Procedures (SOPs) Ability to use automated enterprise testing tools to support and assist company’s testing initiatives.
• Experience with one of the following testing tools is an asset: Quality Center, LOADRUNNER, or QUICKTEST PRO.
• Working knowledge of relevant technology, tools and software; knowledge of UNIX, SDLC, Desktop services, HP Test tools, or equivalent testing tools.
• Excellent teamwork and interpersonal skills; excellent relationship building skills
• Ability to communicate effectively both orally and in writing
• Strong analytical, problem-solving and conceptual skills
• Excellent organizational skills; attention to detail
• Ability to resolve system issues effectively and efficiently
• Ability to prioritize work load and consistently meet deadline
Xlysi LLC, Expert Portal Solutions
774 Eayrestown Rd., Lumberton, NJ 08048
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