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Validation Specialist

Company Name:
Sonar Products
Sonar Products, Inc. is looking to add a Validation Specialist to the team.
Please see a list of duties that pertain to the position.
Responsibilities for the Validation Specialist position generally include but not limited to:
Support, develop, and maintain standard validation processes
Provide specialist validation support for change control
Develop and review user requirement specifications
Analyze data associated manufacturing and regulatory requirements to assess their effect on the Internal Quality System.
Develop validation protocols and associated summary reports
Ensure facility validation strategies and policies are followed and in compliance.
Assist with investigations, root-cause analysis and corrective and preventive actions as needed
Coordinate and collate site quality metrics
Analyze data and work with to solve technical problems
Requirements:
Associates degree with a minimum 2 years of quality related experience. (Bachelors degree and experience working in the pharmaceutical industry are not required but strongly preferred.)
Must be able to perform good record keeping.
Basic technical writing skills needed.
Must be able to speak, read and write English.
Working knowledge of computers including word processing, and spreadsheets.
Knowledge of ISO and FDA requirements for GMP/GLP practices.
Experience working in a FDA regulated manufacturing facility.
Ability to prioritize workload to meet established deadlines.
Ability to use scientific rules and methods to solve problems.
Critical Thinking - Use logic and reasoning to identify the strengths and weaknesses of alternative solutions, conclusions or approaches to problems.
Writing - Communicating effectively in writing as appropriate for the needs of the audience.
Reading Comprehension - Understanding written sentences and paragraphs in work related documents.
Sonar Products is an Equal Opportunity Employer.

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