Quality Assurance Operations Analyst

2 weeks ago


Novato, California, United States Compass Consulting Full time

About Us: Compass Consulting is dedicated to advancing healthcare solutions through innovative therapeutics aimed at addressing serious and life-threatening rare genetic disorders.

Position Overview:

This role, reporting to the Quality Assurance Supervisor/Manager/Senior Manager, is pivotal in ensuring quality compliance across various processes involved in the manufacturing and release of products.

Key Responsibilities:

  • Oversee quality assurance for multiple operational facets, ensuring adherence to Good Manufacturing Practices (GMP).
  • Conduct direct observations of manufacturing processes to verify compliance with established standards.
  • Review and assess GMP documentation, including logbooks, batch records, and testing documentation.
  • Issue Production Batch Records to the manufacturing team.
  • Manage the scanning and archiving of completed production batch records.
  • Ensure that manufacturing and quality control operations align with company policies, regulatory requirements, industry standards, and GMP regulations.
  • Possess a working knowledge of regulatory requirements and guidelines from the United States and Europe, with additional jurisdictions being a plus.
  • Revise quality assurance-related procedures as necessary to maintain compliance and efficiency.

Qualifications:

  • Associate's Degree is required; Bachelor's Degree is preferred.
  • Strong attention to detail is essential.
  • Proficiency in MS Office applications.
  • Ability to operate standard office equipment effectively.


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