Laboratory Specialist
2 weeks ago
Job Title: Quality Assurance Specialist
Roles & Responsibilities
- The incumbent will conduct quality control analyses in compliance with laboratory and analytical methods, ensuring that quality, safety, health, and environmental standards are met.
- Assist in other functions such as documentation and preparation of standard operating procedures.
Responsibilities
- Perform and carry out analytical testing in compliance with specifications, Analytical Methods, Laboratory Methods, and pharmacopoeia requirements.
- Assist in monitoring the calibration and maintenance program for laboratory instruments/equipment and ensure compliance with established schedules.
- Qualify laboratory equipment and validate analytical methods to ensure accuracy and reliability.
- Ensure that analyses are carried out and reported in accordance with Good Laboratory Practices (GLP).
- Report and trend test results to identify areas for improvement.
- Plan and assure cGMP-compliant quality testing and documentation according to schedule.
- Prepare laboratory reagents in compliance with GLP and laboratory Standard Operating Procedure (SOP) requirements.
- Source reagents/laboratory consumables while considering departmental targets.
- Participate in departmental activities as required and maintain and develop all required laboratory documents.
- Responsible for electronic raw data handling in compliance with regulations and guidelines.
- Ensure safe working in the laboratory by practicing and communicating safety protocols.
Requirements:
- Familiar with analytical equipment (e.g., HPLC, GC, etc.).
- Able to work shift on a rotational basis.
- Analytical, methodical, and quality-conscious.
- Good knowledge of FDA regulations and cGMP.
- Degree in chemistry/chemical process technology/bio-process technology or an ITE graduate.
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