Validation Specialist

West Point, Pennsylvania | Freelance | Job ID #57398 |
Posted Last Month
 

Our client is looking for a Validation Specialist to 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 Validation Documents (Risk Assessment, Validation Plan, Design Configuration/Specification, User Requirements, Functional Requirements, IQ OQ PQ, Trace Matrix, Validation Summary Report), SOPs, Maintenance Procedures, Calibration Procedures, and other instrument support documents
  • Translate technical information and requirements into qualification/validation test design
  • Contribute to the overall growth of our clients 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

Employer Details:

  • Onward Search is an equal opportunity employer, dedicated to a policy of non-discrimination in an employment with regard to race, color, religion, gender, sexual orientation, national origin, age, disability, genetic information, veteran status or any other classification protected by federal, state and local laws and ordinances. Candidates must be at least 18 years old to be considered for employment. EOE/M/F/D/V/SO.
  • In compliance with federal law, all persons hired will be required to verify identity and eligibility to work in the United States and to complete the required employment eligibility verification document form upon hire.
  • The client is unable to support 1099 / Corp-to-Corp or Independent Contractor arrangements at this time. All freelancers will be paid as W2 employees.
  • Onward Search is a drug-free workplace.
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About Onward Search

Onward Search helps connect creative, marketing, and technology talent with top jobs at the nation's most recognized companies and digital agencies. We offer a full range of recruitment and staffing solutions to include freelance / contract, temp-to-perm, and permanent placement.