Thermo Fisher Scientific—Validation Analyst

Job description

Description: Work Schedule Standard (Mon-Fri) Environmental Conditions Office Job Description Qualifications: Education and Experience: Bachelor's degree or equivalent and relevant formal academic / vocational qualification Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 3+ years). In some cases, an equivalency, consisting of a combination of appropriate education, training and/or directly related experience, will be considered sufficient for an individual to meet the requirements of the role. Knowledge, Skills, and Abilities: - Client focused approach with strong interpersonal skills, and strong oral and written communication skills and ability to teach others - Strong attention to details and problem-solving skills - Demonstrated competency with Microsoft Office Suite (Word, Excel, PowerPoint, and Project). Proven ability to learn new computer software with minimum of instruction - Positive attitude, enthusiasm toward work, and the ability to work well with others - Strong organization and time management skills with the ability to adapt and adjust to changing priorities and manage multiple assignments with challenging/conflicting deadlines - Solid understanding of clinical trials operational processes and terminology and solid understanding of the software development life cycle (SDLC) - Strong troubleshooting skills and ability to analyze software defects, assess the cause of test failures, and explain how errors are produced - Ability to attain, maintain, and apply a working knowledge of GCPs, applicable SOPs/WPDs, and process maps - Ability to review and critique SDLC documentation including requirements, functional design, system design, and test plans. Ability to assess the cause of test failures - Demonstrated ability to coordinate project activities and work and communicate effectively on a multi-disciplinary team Policy and Strategy: <Policy Strategy> Management Role: No management responsibility Working Conditions and Environment: - Work is performed in an office environment with exposure to electrical office equipment. - Occasional drives to site locations with occasional travel both domestic and international. Physical Requirements: - Frequently stationary for 6-8 hours per day. - Repetitive hand movement of both hands with the ability to make fast, simple, repeated movements of the fingers, hands, and wrists. - Frequent mobility required. - Occasional crouching, stooping, bending and twisting of upper body and neck. - Light to moderate lifting and carrying (or otherwise moves) objects including luggage and laptop computer with a maximum lift of 15-20 lbs. - Ability to access and use a variety of computer software developed both in-house and off-the-shelf. - Ability to communicate information and ideas so others will understand; with the ability to listen to and understand information and ideas presented through spoken words and sentences. - Frequently interacts with others to obtain or relate information to diverse groups. - Works independently with little guidance or reliance on oral or written instructions and plans work schedules to meet goals. Requires multiple periods of intense concentration. - Performs a wide range of variable tasks as dictated by variable demands and changing conditions with little predictability as to the occurrence. Ability to perform under stress. Ability to multitask. - Regular and consistent attendance. Skills: sdlc, clinical trials operations, software troubleshooting, test plan review, project coordination, stakeholder communication, documentation review, time management, problem solving, oral communication, written communication, gcp knowledge, process mapping, requirements analysis