Quality Control

2 weeks ago


Kuala Lumpur, Malaysia CELL BIOPEUTICS RESOURCES SDN BHD Full time

We are currently seeking an energetic and experienced individual with cell therapy quality control background. You will also be expected to independently organize, analyse, and present results and conclusions.

The individual will work as part of the QC team in collaboration with Manufacturing, Process Development, and Research teams to advance diverse projects while adhering to communicated timelines.

**Key responsibilities**:

- Receive and manage samples: The QC Specialist will be responsible for receiving and tracking all samples, ensuring that they are properly labelled, accounted for, and stored.
- Coordinate sample shipment and testing: The QC Specialist will coordinate the shipment of samples to internal and external testing facilities and ensure that all necessary documentation is in place.
- Receive, review, archive, and trend test results from external testing laboratories: The QC Specialist will receive and review the test reports to ensure that they meet quality standards. The QC Specialist will maintain a complete and organized archive of all test results, including trending analysis and documentation as needed.
- Support in-house QC testing: The QC Specialist may assist in-house quality control testing as needed.
- Review test records and other documents: The QC Specialist will review test records and other related documents to ensure accuracy and compliance.
- Assist investigations: The QC Specialist will assist non-conformance investigations and draft investigation reports.
- Coordination with Quality Assurance: The QC specialist will assist in the compilation of data packages to provide to the Quality Assurance team to facilitate release of raw materials or finished products.

**Qualifications**:

- MS in biological sciences or a related field is required.
- 3+ years of relevant experience in cell therapy or Biotechnology industry is required.
- Experience in cGMP procedures is strongly preferred.
- Experience in at least two areas of the followings is required: cell culture, cell-based assays, immunoassays, and flow cytometry.
- Experience with cell therapy QC methods is highly desired.
- Ability to analyze and interpret complex data.
- Excellent communication and interpersonal skills.
- Ability to work independently, multitask, and meet deadlines in a fast-paced environment.
- Highly motivated, organized, detail oriented, and disciplined record keeping.

**Salary**: RM3,000.00 - RM4,000.00 per month

Schedule:

- Monday to Friday

Ability to commute/relocate:

- Kuala Lumpur: Reliably commute or planning to relocate before starting work (required)

Expected Start Date: 01/01/2024



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