Quality Engineer 
6 months
100% Remote (Ideally Eastern Time, preference for Boca-area proximity, may need occasional collaboration

• Minimal travel, possibly for equipment testing sessions

Quality Engineer focused on:

• Equipment validation documentation
• Technical writing
• Report generation
• SOP development
• Statistical review of test results
• CGMP compliance
• Quality Systems validation support

This is tied to a broader process innovation project.
 
Core Responsibilities
Validation Documentation

• Write/review/approve validation protocols (IQ/OQ/PQ)
• Technical reports tied to systems and equipment
• Equipment validation documentation (not executing, writing)

Reporting & Statistical Analysis

• Summarize testing results
• Ensure acceptance criteria are met
• Identify process anomalies
• Ensure reliability standards are satisfied

Quality Systems Support

• Work with quality systems validation program
• Collaborate with change management and quality teams
• Help develop and maintain SOPs (using internal templates)

 
Required Background
Education

• Bachelor’s in Engineering or Sciences

Experience

• Pharmaceutical or highly regulated industry
• CGMP principles
• Validation experience (equipment preferred)
• Quality systems experience
• Technical writing experience

Preferred Industry

• Medical device or pharmaceutical manufacturing
• FDA-regulated environment

  
 
At SPECTRAFORCE, we are committed to maintaining a workplace that ensures fair compensation and wage transparency in adherence with all applicable state and local laws. This position’s starting pay is: $ 76.92/hr.