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Validation Specialist-Remote Position Los Angeles United States, San Francisco United States,  

PerkinElmer (company)


Posted on : 19 May 2017

Project Description

Job Description : 
  • Our company  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 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 our company 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
  • 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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