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Validation Analyst Ii

Company: Altasciences
Location: Bremerton
Posted on: June 24, 2022

Job Description:

Altasciences is a forward-thinking, mid-size contract research organization offering pharmaceutical and biotechnology companies a proven, flexible approach to preclinical and clinical pharmacology studies, including formulation, manufacturing and analytical services. For over 25 years, Altasciences has been partnering with sponsors to help support educated, faster, and more complete early drug development decisions. Altasciences' integrated, full-service solutions include preclinical safety testing, clinical pharmacology and proof of concept, bioanalysis, program management, medical writing, biostatistics, and data management, all customizable to specific sponsor requirements. Altasciences helps sponsors get better drugs to the people who need them, faster.The Validation Analyst II and member of the Validation department participates in all phases of Computerized System Validation (CSV) including the planning, writing, editing, assessment of regulatory risk and review of the following validation deliverables; project plans, validation plans, system requirements, test plans, test scripts, traceability matrix, exception reports, and summary reports. The Validation Analyst II will participate in the development, revision and maintenance of validation documentation such as the master validation plan, validation SOPs, and quality management systems designed to assist in the organization, planning, execution, monitoring, and reporting of validation activities.Essential Job Responsibilities: Interpret and implement industry best practices, regulatory requirements such as GLP, 21 CFR Part 11 and corporate policy. Contribute to the development and maintenance of validation quality management system (e.G. Master Computerized Systems List, a Master Validation Schedule, and Validation Department SOPs). Oversees projects, including the scheduling of resources, tasks, and providing project status reports. Advise internal departments during procurement of regulated software on applicable compliance requirements. Generate and maintain validation deliverables to support the execution of computerized system validation activities. Monitor the execution of test plans, acceptance criteria and test results for computerized system validation activities. Monitor and provide assistance for vendor supplied computerized system validation services. Maintain inventories, lists, status, and other tracking tools of approved validation documentation, system configuration, change control, etc. Ensure adherence to change management procedures for validated systems. Conduct technical assessments on change control, system usage SOPs, etc. for validation compliance and impact. Respond to internal/external audit findings and contribute to corrective actions as needed.Job Requirements: B.S./M.S. degree, preferably in scientific or technical discipline or equivalent combination of education, related experience and/or certified training. 5+ years of computerized system validation experience within the GLP/GMP regulated environment (i.E., 21 CFR Part 11 and 58). Good procedural and technical documentation skills. The math skills required include but are not limited to: a working knowledge of applied mathematics used in the life sciences industry, advanced algebra, regression analysis, and statistics. Proficient in the use of MS Office (Word, Excel, Visio, PowerPoint) and project management tools. Ability to write routine reports and correspondence; excellent oral and written communications and teamwork skills; demonstrates excellent written and oral communications skills for interaction with a multidisciplinary project team; and the ability to speak effectively before groups of customers or employees of the organization.Altasciences is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, or national origin, and protected veteran status, or disability status. Altasciences uses E-Verify to confirm the employment eligibility of all newly hired employees. To learn more about E-Verify, including your rights and responsibilities, please visit www.E-Verify.Gov. INDMP

Keywords: Altasciences, Seattle , Validation Analyst Ii, Professions , Bremerton, Washington

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