Senior Quality Assurance Specialist

4 weeks ago


San Francisco, United States Jaguar Health Full time

  • Responsible for batch record review and disposition of API and Drug Product lots with reference to approved specifications.
  • Review, revise and maintain standard operational procedures (SOP) and specifications.
  • Review for administration of deviations, out of specification (OOS), and out of trend (OOT) events and participate in preparation of reports.
  • Create and administer change control records and follows up on completion of changes.
  • Participate in risk assessment and gap assessment as it relates to maintaining compliance with safety, quality and regulatory standards.
  • Facilitate employee training on current SOPs according to GxP requirements and archives training records.
  • Experienced in MasterControl Quality Management System, especially as a system administrator.
  • Experienced in making independent decisions related to controlled document management.
  • Responsible for GxP controlled document management and archiving.
  • Responsible for attaining and archiving of relevant records from CMOs and Contract labs.
  • Perform activities to maintain and improve quality systems.
  • Other responsibilities include supporting manufacturing, clinical operations, and supply chain departments as necessary.


REQUIREMENTS

  • Knowledge of GMP rules and regulations and ICH guidelines
  • Bachelor's or Master's degree in chemistry or one of the life science disciplines
  • Minimum 5 years' experience Quality Assurance of Pharmaceutical/ biotech industries
  • Knowledge and experience with MasterControl as a system administrator with special focus on quality systems, document management, and training modules
  • Proficient in Word, Excel, and PowerPoint
  • Strong verbal and written communications skills
  • A team player



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