Validation Analyst Ii
Company: Altasciences
Location: Bremerton
Posted on: June 24, 2022
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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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