Quality Assurance Specialist
About the Role:
We are seeking a detail-oriented and analytical Quality Assurance Specialist to join our team. The successful candidate will be responsible for ensuring compliance with regulatory requirements, testing pharmaceutical drug substances, and maintaining high standards of quality.
Key Responsibilities:
* Conduct thorough testing and analysis of drug substances according to valid procedures and regulations.
* Maintain laboratory equipment in good working condition, performing calibrations as required.
* Evaluate results generated by other analysts for accuracy and compliance.
* Meet project deadlines and communicate progress at regular meetings.
* Ensure laboratories are well-organized and safe working environments.
* Assist in method transfers, validation of test methods, and development of documentation.
* Lead investigations into deviations and laboratory incidents.
* Review and close out batch analysis, identifying areas for improvement.
* Maintain knowledge of cGMPs, analytical techniques, and safety protocols.
* Identify opportunities for process improvements and collaborate with leadership for implementation.
* Foster a culture of continuous learning and self-improvement.
* Adhere to company policies on health, safety, and equality.