The QC Officer is responsible for performing laboratory testing, documentation, and quality-related activities to support the manufacturing and release of cell therapy products in a GMP-regulated environment. The role ensures that all analytical activities are conducted in accordance with regulatory requirements, internal policies, and international quality standards.
Key Duties and Responsibilities
- Conduct QC testing for raw materials, in-process samples, and final products, including sterility assays, endotoxin testing and immunophenotyping via flow cytometry.
- Execute environmental monitoring sample testing as required.
- Ensure all QC activities comply with GMP, SOPs, and data integrity principles (ALCOA+).
- Maintain accurate laboratory documentation, worksheets, and logbooks.
- Support method validation, equipment qualification, and instrument calibration.
- Assist in investigation of deviations, out-of-specification results, and corrective actions.
- Contribute to preparation, review, and controlled document updates.
- Participate in internal and external audits.
- Ensure laboratory readiness through routine housekeeping, inventory control, and adherence to safety protocols.
Qualifications and Experience
- Bachelor’s degree in a science-related discipline (Biotechnology, Biomedical Science, Molecular Biology, Microbiology, etc.).
- Prior QC or GMP laboratory experience is not required but is preferred. Candidates without experience will be considered if they demonstrate strong technical aptitude and willingness to learn.
- Experience with qPCR, endotoxin assays, aseptic handling, or flow cytometry is advantageous.
- Understanding of GMP regulations, PIC/S standards, or ATMP-related guidelines is beneficial but not mandatory.
- Only Malaysians need to apply
Competencies
- Highly organised and detail oriented.
- Strong communication skills and ability to work independently or as a part of team.
- Good analytical and problem-solving abilities.
- Good proficiency in English with strong technical writing skills
Job Type: Full-time
Pay: RM2,500.00 - RM3,200.00 per month
Benefits:
- Additional leave
- Free parking
- Health insurance
- Maternity leave
- Parental leave
- Professional development
Application Question(s):
- This position is open only to Malaysian Citizen
Education:
Experience:
- qPCR, endotoxin assays, : 1 year (Preferred)
- aseptic handling, or flow cytometry : 1 year (Preferred)
- Prior QC or GMP laboratory : 1 year (Preferred)
Language:
- Good English with strong technical writing skills (Required)
Work Location: In person