Deskripsi Pekerjaan
We are seeking a meticulous QA/QC Specialist to join our prestigious biopharmaceutical multinational in the West Region. This critical role ensures product quality compliance through rigorous testing, documentation, and adherence to industry standards. You'll work in a state-of-the-art laboratory environment, safeguarding product integrity from raw materials to final release. The position offers competitive compensation and career advancement within a globally recognized organization. Ideal candidates will demonstrate strong analytical skills and commitment to regulatory excellence in the pharmaceutical sector.
Tanggung Jawab
- Conduct routine and non-routine quality control testing of raw materials, in-process samples, and finished products
- Maintain accurate batch records, lab notebooks, and quality documentation
- Investigate product deviations and implement corrective actions (CAPA)
- Ensure compliance with GMP/GLP standards and regulatory requirements
- Perform equipment calibration and maintenance verification
- Collaborate with cross-functional teams on quality improvement initiatives
- Participate in internal/external quality audits
- Analyze test data and prepare quality reports for stakeholders
Kualifikasi
- Bachelor's degree in Chemistry, Biology, Pharmacy, or related Life Sciences field
- Minimum 2 years' experience in biopharmaceutical QA/QC environment
- Strong knowledge of GMP/GLP and ISO standards
- Proficiency in analytical techniques (HPLC, GC, UV-Vis, etc.)
- Excellent documentation and record-keeping skills
- Ability to troubleshoot complex quality issues
- Strong attention to detail and problem-solving abilities
- Effective communication and teamwork skills