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Quality Assurance Validation Specialist

2 months ago


Lake Bluff, Illinois, United States Blue Star Partners, LLC Full time

Job Title: Validation Analyst - C
Company: Blue Star Partners, LLC
Contract Type: W2 only

Position Overview:

The Validation Analyst - C will spearhead and assist in validation initiatives and deliverables for projects necessitating validation. This position encompasses the development and execution of validation test scripts, thorough documentation of test outcomes in line with established standards, and the assessment and evaluation of validation reviews for application systems and projects. The analyst will also be tasked with the revision of Validation Policies and Standard Operating Procedures (SOPs) as required, ensuring that validation documentation is accurately filed in accordance with Quality Assurance Library protocols.

Key Responsibilities:

  • Lead and support validation initiatives across diverse projects.
  • Develop and execute validation test scripts, documenting results per company standards.
  • Assess and evaluate validation reviews for application systems and projects.
  • Revise Validation Policies and SOPs as necessary.
  • Ensure proper filing of validation documentation within Quality Assurance Library protocols.
  • Communicate effectively with team members and stakeholders.
  • Maintain a strong customer service orientation.

Qualifications:

  • Minimum of an Associate Degree or an equivalent combination of education and professional experience.
  • At least 2 years of experience with validated systems in a regulated environment.
  • Experience in drafting Standard Operating Procedures and validation policies.
  • Advanced understanding of IT concepts.
  • Proficiency in word processing and spreadsheet applications.
  • Knowledge or experience in laboratory, product, and manufacturing settings is advantageous.

Essential Skills:

  • Exceptional verbal and written communication abilities.
  • Strong focus on customer service.
  • Solid background in Information Technology.
  • Experience in a Quality/Regulated environment.
  • Background in System Audit/Validation.
  • Excellent organizational and project management capabilities, including familiarity with the Software Development Life Cycle (SDLC).