Job Description:
We are seeking a highly skilled and experienced Quality Assurance Specialist to join our team. As a Senior Associate QC, you will work under minimal supervision, responsible for one or more of the following activities: analytical testing in process, stability, and finished products.
Key responsibilities include:
1. Testing of in-process, stability, and finished product samples using HPLC, CE, SDS-PAGE, IEF analytical testing, characterization, and sample/data management
2. Review and authorization of Lab Data
3. Support Analytical Technical Transfer activity testing reports and documentation
4. Document review/updates when required
5. Equipment Calibration, Maintenance, and Trouble Shooting
6. Method Validation/Verification
7. Training of QC Chemistry Laboratory colleagues
8. Laboratory Investigation support
9. Laboratory Housekeeping and maintaining GMP standards
10. Assisting in regulatory audits
Requirements:
* Hold a third-level qualification (Degree/Diploma) in Biochemistry, Chemistry, Biology, Biotechnology, or similar Scientific Subject
* 5+ years relevant experience in a pharmaceutical/healthcare environment
* Strong technical writing skills
* Detail-oriented, self-motivated with good troubleshooting/problem-solving abilities
* Experience with analytical techniques such as HPLC, CE, SDS-PAGE, IEF testing advantageous