Quality Assurance Tech Iv

Endogastric Solutions

St. Louis, United States
Office environment (95% office, 5% manufacturing exposure)
6-8 years gmp document review experience
Fda and cgmp regulatory knowledge
Bpcs and lims system proficiency
Endogastric Solutions is seeking a Quality Assurance Technician IV to provide high-level administrative support in product release processes while mentoring junior staff. The ideal candidate should possess extensive knowledge of GMP regulations and experience in a similar role, demonstrating strong communication and problem-solving skills

Job Summary

  • The role serves as a key decision maker in the product release function while coordinating with various departments to meet shipping schedules.
  • Incumbents are expected to act as a lead or mentor to junior personnel with minimal supervision required for complex tasks.
  • The position requires extensive knowledge of products, raw materials, inventory planning, and quality systems within a GMP environment.

Matching Summary

Match Score: 85

Endogastric Solutions is seeking a Quality Assurance Technician IV to provide high-level administrative support in product release processes while mentoring junior staff. The ideal candidate should possess extensive knowledge of GMP regulations and experience in a similar role, demonstrating strong communication and problem-solving skills.

Skills & Requirements

Must-have

  • 6-8 years GMP document review experience
  • FDA and cGMP regulatory knowledge
  • BPCS and LIMS system proficiency
  • API and DP material release expertise
  • Complex batch record analysis skills

Nice-to-have

  • Mentoring junior QA personnel
  • Cross-functional collaboration abilities
  • High-level communication skills
  • Independent problem-solving initiative
  • Priority setting in shipping schedules

Key Requirements

  • Minimum 6-8 years in GMP document review
  • Proven FDA and cGMP regulation knowledge
  • HS Diploma required; Bachelor's preferred
  • Proficiency in BPCS and LIMS systems

Work Rights

Not specified

Tailored Resume

Cover Letter