Deskripsi Pekerjaan
Join Thermo Fisher Scientific as a Senior QC Chemist and play a pivotal role in ensuring product quality and regulatory compliance in our biologics manufacturing facility. This position offers an opportunity to work in a dynamic, GMP-regulated environment where you'll conduct advanced analytical testing, validate methodologies, and optimize laboratory operations. You'll collaborate with cross-functional teams to investigate deviations and implement corrective actions, maintaining the highest standards of quality control for life-saving therapeutics. The 12-hour rotating shift schedule provides a flexible work-life balance while contributing to critical quality assurance processes that impact patient health worldwide.
Tanggung Jawab
- Execute GMP-compliant analytical testing for biologics products using advanced instrumentation (HPLC, GC, UV-Vis)
- Lead method validation, verification, and transfer activities for new/modified analytical procedures
- Investigate out-of-specification results and implement CAPA processes
- Maintain calibration and maintenance of laboratory equipment
- Train junior chemists on SOPs and analytical techniques
- Document all QC activities in compliance with 21 CFR Part 11 requirements
- Participate in internal/external audits and regulatory inspections
Kualifikasi
- Bachelor's or Master's degree in Chemistry, Biochemistry, or related field
- Minimum 5 years QC experience in GMP-regulated biopharma environment
- Strong expertise in analytical method validation and instrument qualification
- Proficiency with HPLC, GC, and dissolution testing methodologies
- Knowledge of ICH guidelines and regulatory requirements (FDA, EMA)
- Experience with LIMS systems and electronic batch records
- Certification in GMP or related quality systems preferred
- Ability to work independently in a rotating shift schedule