Job Title:
Quality Assurance Assistant
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About the Role:
This is an exciting opportunity to join our Quality Assurance team as a Quality Assurance Assistant. In this role, you will play a key part in ensuring the quality of our products and processes.
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Key Responsibilities:
* Maintain the Documentation Control System and associated files throughout their lifecycle.
* Ensure the Quality Management System (QMS) is up-to-date and its software (Pragma and Adhoc) is utilized effectively.
* Review manufacturing and cleaning records for adherence to cGMP.
* Verify shipment documentation and containers before release.
* Issue materials such as intermediates to production teams.
* Perform Good Manufacturing Practice (GMP) Walkthroughs as scheduled.
* Monitor temperature and humidity data.
* Provide proactive reporting and responses to quality-related issues.
* Support the preparation of quality documentation and QMS processes.
* Conduct visual inspections during cleaning activities.
* Deliver training sessions as needed.
* Assist with audit preparation.
* Perform general administrative duties for the Quality Assurance department.
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Requirements:
* Adhere to cGMP and EHS practices at all times.
* Liaise with supervisors to ensure rapid issue communication and project progression.
* Maintain the Documentation Control System and ensure documentation updates follow change control and good documentation practices.
* Critically review manufacturing, cleaning, and shipment documentation for cGMP adherence.
* Support other departments with quality documentation and QMS processes.
* Perform general administrative duties for the department.
* Show interest in quality assurance activities and opportunities for improvement.
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Working Conditions:
This role is primarily office-based within the Quality Assurance Department, with some duties performed in GMP areas such as production, quality control, and warehouses.
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Performance Evaluation:
1. General timekeeping and attendance.
2. Work output.
3. Quality of workmanship.
4. Compliance with agreed work schedule and program.
5. Health, Safety, and Environmental and Quality practices.
6. Ability to work in a team environment.
7. Ability to work independently.
8. Work attitude.
9. Training and self-development.
10. Contribution to improving the department.
11. Overall team performance.
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Estimated Salary:
$60,000 - $80,000 per annum, depending on experience.