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Validation Specialist Los Angeles United States, San Francisco United States,  


Posted on : 14 May 2017

Project Description

Job Type : Contract Career Level : Experienced (Non-Manager) Education : Bachelor's Degree Location : 1. Los Angeles CA US 2. San Francisco CA US Job Description : PerkinElmer is a global technology leader driving growth and initiative in the Environmental and Human Health Science markets. The company is a leading force in the development, production, marketing, servicing, and support of laboratory instrumentation and ancillary services throughout the world. Job Title: Validation Specialist Location: Remote Home Based Position in the West Coast (CA) – preferably the Greater San Francisco Bay or Los Angeles Areas Duration: Long Term   Job Description: Job Purpose: Support Compliance Projects and Programs   Core Job Duties: Design, Author, and Execute Computerized System Validation (CSV) – according to GAMP 5 guidance – especially on Analytical Laboratory Test Equipment and other Lab Information Systems Technical Writing of Qualification Protocols (IQOQ), Calibration Procedures, and other instrument support documents Pre-Qualification/Validation activities, such as system risk assessments Translate technical information and requirements into qualification/validation test design Contribute to the overall growth of PerkinElmer’s compliance business   Qualifications, Skills & Experience: Bachelor’s Degree; scientific background preferred At least 3-5 years of pharmaceutical of FDA related validation experience Good knowledge of GMPs, 21CFR Part 11, USP 1058 – and other relevant industry regulations and guidance Strong interpersonal skills and demonstrated ability work independently Organized and task oriented Excellent written and oral communication skills – especially on technical topics Self-directed and motivated individual who is able to operate in a rapidly changing business environment Customer-oriented, conducting job function with a primary focus on customer satisfaction (internal & external) and ability to deal with customer complaints Must have a strong command of Microsoft Office Word and Excel and Adobe Acrobat, Microsoft Project Ability to Build consensus among team of stakeholders Excellent critical thinking/analytical and problem solving skills Experience with a multitude of laboratory equipment a plus     Work Conditions: Lab Environment (may need to follow Personal Protective Equipment and Safety Polices); Office Environment.   Benefits at PerkinElmer Competitive base salary and incentive compensation plan / Job training and professional development / Comprehensive benefits package / Paid time off and holidays / Tuition reimbursement plan / 401(k) with match

Locations

Los Angeles CA USSan Francisco CA US

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