Quality Assurance Assistant (ISO 15189)

Mô tả Công việc

1. Document control and record (50%)
1.1. Document control (20%)
- Support QA specialist issue new procedure to related department (arrange hard copy and soft copy).
- Support QA specialist obsolete the old version of procedure (arrange file hard copy and soft copy).
1.2. Ad-hoc document revision (30%)
- Receive the request from Lab or other departments to update the SOPs/QSPs.
- Issue new procedure to related department (arrange hard copy and soft copy).
- Obsolete the old version of procedure (arrange file hard copy and soft copy).

2. EQA program (40%)
2.1.Sample receive and distribution (5%)
- Receive samples from vendors.
- Checking the quality of specimen (Lot/date, temperature, quantity)
- Handover to related departments
- Fill records.
2.2. Result submission (10%)
- Checking raw data and result sheet.
- Submit data on portal.
2.3. Result evaluation (10%)
- Receive evaluation report from portal --> analyze result.
- Arrange the hard copy and soft copy.
- Input data to monitor on excel sheet + email to Lab.
2.4. Corrective action and preventive action (15%)
- Identify the outlier in the evaluation report and notify the department for CAPA.
- Review the CAPA and follow up with evidence.
- Tracking CAPA.

3. Stationery management (20%)
- Monitor the stock of stationery of QA.
- Plan for order in advance.
- Raise Jira request for ordering.

Yêu Cầu Công Việc

- At least 1 year of experience in quality assurance (ISO 9001 & ISO 17025 & ISO 15189)
- Graduated major related to Medical.
- Good computer skills MS Office (Word, Excel, PowerPoint).
- Can communicate in English and read document in English.
- Good in documentation and good grasping power.
- Good time management in completing tasks.
- Team works attitude and critical thinking.