About the Role
We are seeking a QC Analyst to support quality control operations within our biotech drug substance site. The role is responsible for executing laboratory testing, sample management, and equipment maintenance in compliance with cGxP standards, ensuring the quality and timely delivery of products.
Key Responsibilities
- Perform analytical testing and documentation of raw materials, drug substances, drug products, packaging, complaints, and stability samples
- Manage sample storage and stability programs
- Maintain, calibrate, and qualify laboratory equipment
- Ensure compliance with cGxP, data integrity, and HSE guidelines
- Participate in training and contribute to continuous improvement initiatives
Performance Measures
- Accurate and timely completion of analysis and documentation
- Compliance with GMP, SOPs, and regulatory standards
- Readiness for inspections with no critical findings
- Contribution to cost and process optimization
Qualifications & Experience
- Diploma, apprenticeship, or equivalent training in a relevant scientific field (e.g., Chemistry, Biochemistry, Biotechnology, Life Sciences)
- Preferably with 2-5 years of experience in a pharmaceutical laboratory environment (QC, QA, or production)
- Knowledge of GMP/cGxP standards, laboratory techniques, and QC processes
- Strong teamwork, resilience, and problem-solving skills
- Basic proficiency in English
Why Join Us
This role offers the opportunity to directly impact product quality, compliance, and patient safety while working in a collaborative and innovative environment.
