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Quality Assurance Specialist
2 months ago
Rubicon Research is seeking a highly skilled Quality Assurance Associate to join our team. As a Quality Assurance Associate, you will play a critical role in ensuring the quality and compliance of our analytical and formulation method development and stability testing activities.
Key Responsibilities- Quality Review and Compliance
- Review and approve laboratory investigations, incidents, deviations, and other technical write-ups for quality management system notifications.
- Track timely completion of quality management system notifications.
- Perform quality review of the analytical data package of various tests (e.g., HPLC testing).
- Review and manage change control activities.
- Review and approve equipment qualification.
- Review and release calibration standards of instruments such as weights, pipettes, thermometers, timers, hygrometers, etc.
- Issue logbooks/laboratory notebooks and follow up with proper documentation.
- Follow up with the training of each personnel and ensure such trainings are up to date.
- Ensure all work performed in the laboratories is in good manufacturing practice (GMP) compliance.
- Review and monitor quality agreements, device suppliers, contract manufacturing organizations (CMOs), and GMP batches.
- Perform monthly audits.
- Support CMO management activities.
- Review and approve vendor qualification/service provider documentation.
- Bachelor's degree in Chemistry and Pharmaceutical Sciences.
- Minimum of 4+ years of experience in the pharmaceutical industry.
- Minimum of 2+ years' experience in analytical testing setup (GMP).
- Knowledge of HPLC testing and familiarity with Empower is a must.
- Familiarity with analytical method development in pharmaceutical formulations.
- Previous experience in lab as a technical data reviewer will be considered an asset.
- Previous experience in quality control lab will be considered an asset.
- Great attitude and motivated to learn new skills.
- Good written and oral communication skills.
- 8-hour shift.
- Monday to Friday.
