Quality Control Assistant

CRYOCORD SDN BHD; Selangor; On-site; MYR 30,000 - 60,000; Full time

Job summary

An established industry player is seeking a dedicated Quality Control Specialist to assist in maintaining high standards of quality management. In this role, you will conduct critical testing and analysis for various products, ensuring compliance with safety regulations and quality standards. You will play a key role in the continual improvement of the Quality Management System, providing training and support to colleagues while participating in audits and inspections. This position offers a unique opportunity to contribute to the advancement of quality practices in a dynamic laboratory environment.

Qualifications

• Experience in quality control processes and techniques.
• Familiarity with laboratory safety and compliance standards.

Responsibilities

• Conduct quality control activities and ensure compliance with SOP.
• Manage internal quality controls and participate in audits.

Skills

Quality Control Techniques

Flow Cytometry Analysis

Data Analysis

ISO15189 Standards

Laboratory Safety Regulations

Education

Bachelor's Degree in Life Sciences

Certification in Quality Management

Tools

CFU Assay

Cell Culture Techniques

Environmental Testing Equipment

Job description

Job Description

Assist the Head of the Quality Department and his/her assigned nominee(s) in the following (but not limited to) matters:

1. Responsible for the operational techniques and activities used to fulfill the requirements for quality control.
2. Conduct quality control activities for the company's products in accordance with the SOP, including colony-forming unit (CFU) assay, flow cytometry analysis, etc.
3. Adhere to the SOP at all times and ensure compliance with safety and health regulations of the laboratory.
4. Manage and monitor internal quality controls and participate in Inter-laboratory Comparison programmes such as external quality assessment or proficiency testing programmes.
5. Prepare and record data analysis for all quality control tests.
6. Ensure validation analyses for cleaning, disinfectant, gowning, process, and personnel are carried out as per standards.
7. Check calibration data of equipment or facilities provided by internal and external parties.
8. Conduct and monitor environmental testing for the laboratory facilities.
9. Responsible for the continual improvement of the Quality Management System.
10. Perform other related laboratory processes such as viability tests, cell culture, blood cell count, etc.
11. Maintain standards according to ISO15189, MOH License, cGMP, and other relevant certifications or accreditations.
12. Participate in internal and external audits and regulatory inspections.
13. Provide training to new and existing employees in the department as needed.
14. Perform other duties as assigned by the company.

Other Tasks:

1. Conduct testing for Mesenchymal Stem Cells, including CFU-F assay, cell differentiation, immunophenotyping, microsatellite instability testing, and immunoassays.
2. Conduct testing for CAR-T cell products, such as RCL testing.
3. Conduct testing for bacterial endotoxin and mycoplasma for relevant products.

Note: This position is only open to non-Muslim candidates.