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Quality Assurance Specialist

2 months ago

Albuquerque, New Mexico, United States curiate Full time
Job Summary

We are seeking a highly skilled Quality Assurance Specialist to join our team at Curia. As a Quality Assurance Specialist, you will play a critical role in ensuring the quality and integrity of our products.

Key Responsibilities
  • Provide QA oversight and subject matter expertise for GMP investigations
  • Work with Quality and Operations to ensure facilities and processes are in a constant state of readiness for regulatory and customer inspections
  • Support product complaints, deviations, and failure investigations
  • Contribute to Curia's core values of Curiosity, Urgency, Respect, Integrity, and Accountability
  • Review and close investigations and customer concerns
  • Perform root cause analysis and implementation of corrective action for process-related concerns
  • Recommend and initiate changes to applicable SOPs
  • Support CURIA Compliance department during FDA and other agency inspections as well as customer and internal audits
  • Maintain a working knowledge of government and industry quality assurance codes and standards
  • Participate in site or global projects and improvement efforts, as needed
Requirements
  • Provides guidance and mentorship to team members
  • Fosters a collaborative and positive work environment
  • Champions change
  • Promotes a safe and healthy work environment by actively identifying and addressing potential hazards, following established safety protocols, participating in safety training programs, and fostering a culture of awareness and responsibility among team members
  • Demonstrates strong attention to detail
Education and Experience
  • Bachelor's Degree in Science, Chemistry, Biology, or related field of study, preferred
  • Associate's Degree in Science, Chemistry, Biology, or related field of study
  • Minimum of three (3) years of experience in quality assurance and/or regulatory experience in the Pharmaceutical industry with demonstrated understanding of laboratory, manufacturing, packaging, regulatory, compliance, and quality assurance requirements for biological and drug product manufacturing