Quality Specialist I

Business Elements

Concord, CA, US
Base: $30–$34ph doe; bonus/equity: not specified; ...
100% on-site
21 cfr part 11 data integrity compliance
Gmp regulatory standards knowledge
Certificate of analysis review
Element Materials Technology is seeking a Quality Specialist I for its Concord, CA laboratory, which specializes in pharmaceutical and life sciences testing. The role involves ensuring compliance with regulatory standards and supporting quality operations in a highly regulated environment

Job Summary

  • The Quality Specialist I ensures laboratory services remain compliant with the Quality Manual, client requirements, and applicable regulatory standards.
  • This role plays a key part in supporting the laboratory's pharmaceutical quality operations while maintaining the integrity and reliability of testing services.
  • The position involves initiating and participating in quality event investigations using eQMS MasterControl and supporting client audits.

Matching Summary

Match Score: 85

Element Materials Technology is seeking a Quality Specialist I for its Concord, CA laboratory, which specializes in pharmaceutical and life sciences testing. The role involves ensuring compliance with regulatory standards and supporting quality operations in a highly regulated environment.

Salary

Base: $30–$34/hour DOE; Bonus/Equity: Not specified; Benefits: Not specified

Skills & Requirements

Must-have

  • 21 CFR Part 11 data integrity compliance
  • GMP regulatory standards knowledge
  • Certificate of Analysis review
  • eQMS MasterControl usage
  • Root cause investigation participation

Nice-to-have

  • Excellent time management skills
  • Strong interpersonal communication
  • Attention to detail in documentation
  • Critical thinking abilities
  • Element Values alignment

Key Requirements

  • B.S. in science degree desired
  • 0-2 years pharmaceutical/biotechnology/GMP experience
  • Basic knowledge of industry regulations

Work Rights

Not specified

Tailored Resume

Cover Letter