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Quality Assurance Supervisor

2 months ago

Los Angeles, California, United States Xseer Pharmaceuticals Full time
Quality Assurance Supervisor

Xseer Pharmaceuticals is seeking a Quality Assurance Supervisor to become a vital part of our team. The successful candidate will be tasked with managing all Quality Assurance functions to guarantee adherence to industry standards and regulatory requirements.

  • Oversee the initiation and qualification of facilities
  • Develop and implement GMP quality systems and compliance frameworks
  • Supervise laboratory instrument qualifications and method transfers
  • Establish and uphold a program for analytical assay performance monitoring
  • Manage stability programs for products and materials
  • Ensure proper maintenance and calibration of equipment
  • Lead regulatory agency inspections
  • Responsible for conducting analytical tests and utilizing laboratory equipment
  • Train personnel in aseptic techniques and waste reduction
  • Design processes to enhance efficiency and minimize waste
  • Review and authorize analytical documentation
  • Provide technical guidance during laboratory investigations

Qualifications:

  • Master's degree in a relevant field with at least three years of experience
  • In-depth knowledge of compounding manufacturing processes and GMP regulations
  • Expertise in FDA regulations and current Good Manufacturing Practices (cGMP)
  • Familiarity with United States Pharmacopeia (USP) regulations
  • Proficient in statistical analysis for data evaluation
  • Strong communication and organizational abilities
  • Capability to manage priorities and workflow effectively
  • Experience in developing and executing analytical method validation
  • Ability to lead, mentor, and inspire a team