Validation Analyst 1

Summary Of Objective

The Validation Analyst I is responsible for overall validation project management of small customer account(s) under heavy supervision. Responsibilities include generating and executing validation protocols, assisting in customer audits, and determining customer validation needs.

Essential Duties and Responsibilities

• Performs validation activities to assure compliance to government and customer requirements.
• Prepares validation protocols, validation statements, and master validation plans for new customer/product/system project launch and maintaining existing validated processes/programs at multiple sites.
• Maintains validation package documentation completion, accuracy, and closure, including organizing and coordinating internal and customer approvals.
• Prepares change control and validation history report for customer audits.
• Attends conference calls and customer meetings and effectively communicates project goals and progress to Validation Supervisor/Manager.
• Investigates validation deviations, documenting in formal reports, and assures resolution of corrective action to complete project.
• Customer contact for quality validations activities and manage customer expectations.
• Reviews and interprets customer standards, procedures, and specifications for dissemination relative to process and cleaning validation protocols.
• Reviews production jackets and issuance to ensure that documents meet internal requirements for standards and procedures.

Qualifications

• High School Diploma or GED and/or 1-3 years related experience and/or training.
• Basic Mathematical Skills.
• Basic Computer Skills: Ability to perform basic computer tasks and has the ability to operate common computer programs.
• Minimum Professional Proficiency: Ability to speak in a way that allows one to participate effectively in various conversations. Ability to read various types of standard items addressed to general readers.
• Intermediate Reasoning: Ability to apply common sense understanding to carry out instructions that may be furnished in written, oral, or diagram form. Ability to deal with problems that involve several concrete variables in standardized situations.
• Ability to demonstrate attention to detail.
• Ability to work independently and/or part of a team.
• Ability to follow instructions and respond to management direction.
• Ability to adapt to changing work environments.
• Ability to display a willingness to make decisions.
• Ability to effectively communicate information to various people as the job requires.