QC Analyst
QC Analytical Specialist
Shift Patterns: 2-Cycle and 4-Cycle shifts available
The Opportunity
Join a high-growth, supportive team at a strategic manufacturing site dedicated to the analysis of world-leading Biologics and Vaccines. Operating within a cutting-edge Quality Operations laboratory, you will play a pivotal role in a facility that serves as a cornerstone for global pharmaceutical supply.
Reporting to the QC Manager, the QC Analyst / Senior Technician will support the continued expansion of our laboratory, spearheading analytical method transfers, validations, and high-volume commercial testing.
Key Responsibilities- Bring your energy and technical expertise to a role that balances routine excellence with innovative problem-solving:
- Compliance & Safety: Execute all duties in strict alignment with Company safety policies, cGMP, and cGLP. Drive adherence to global regulatory requirements and internal procedures.
- Laboratory Operations: Perform advanced analytical techniques, including HPLC (HIC, CE, IEX, HP-SEC), Capillary Electrophoresis, and compendial test methods.
- Documentation & Integrity: Peer-review testing documentation to ensure absolute data integrity and maintain /"Right First Time/" KPIs.
- Continuous Improvement: Lead root cause analysis (FMEA, Fishbone, 5 Whys) for system or equipment failures. Participate in writing and revising SOPs and training materials.
- Communication: Participate in daily QC Tier 1 meetings to report on testing progress and deviations.
- Quality Investigations: Support OOS (Out of Specification) investigations and provide subject matter expertise during internal and external audits/inspections.
- We are looking for a collaborative professional who thrives in a fast-paced, compliant environment.
- Education: Bachelor's Degree or higher in Analytical Chemistry, Biochemistry, or a related scientific discipline.
- Experience: 2-3 years in a pharmaceutical laboratory setting.
- Technical Proficiency: Hands-on experience with HPLC systems and associated software is highly desirable.
- Knowledge Base: A strong foundational understanding of cGMP, GLP, and Quality Management Systems (QMS).
- Soft Skills: A proactive approach to safety culture and the ability to travel occasionally for specialized training.
About the Site
Our facility is a premier filling and commercial supply site for vaccines and biologics. Since its inception, the site has seen significant investment, evolving into a center of excellence featuring advanced production units and temperature-controlled logistics.We are a major employer in the region, known for fostering talent through academic partnerships and a commitment to diversity and inclusion.
Core Competencies Required:
- Analytical Method Transfer & Validation
- GMP/GLP Laboratory Operations
- OOS & Laboratory Investigations
- LIMS & Technical Writing
- Sterility Testing Support