As a QC Analyst, you play a key role in ensuring the quality, consistency and compliance of our manufacturing processes and Investigational Medicinal Products (IMPs). You perform analytical testing, support GMP activities, investigate deviations, and collaborate closely with colleagues across QC, QA, Production, R&D and Regulatory Affairs.
Key Responsibilities:
Analytical Testing & Method Support
• Perform analytical methods to monitor productivity, purity and product quality.
• Support assay development, qualification and validation activities.
• Support internal technology transfer of analytical methods to QC.
• Contribute to method validation and GMP troubleshooting activities.
Operational QC Activities
• Perform equipment qualification and support calibration and maintenance activities.
• Conduct incoming material inspections and release activities.
• Support QA activities including CAPAs, change controls and supplier qualification.
• Investigate OOS and OOT results in a timely and structured manner.
• Ensure accurate and compliant documentation according to GMP and GDP requirements.
Cross-Functional Collaboration
• Work closely with QC, QA, Production, R&D and Regulatory Affairs teams.
• Communicate results, deviations and risks clearly and proactively.
• Participate in or lead small investigations and continuous improvement initiatives.
Continuous Improvement
• Stay up to date with scientific and regulatory developments.
• Contribute to innovation in analytical methods and QC strategies.
• Help strengthen SIMABS as a reliable and innovative partner for future clients.
Vereisten
Education & Experience
• Bachelor's or Master's degree in Biomedical Sciences, Biomedical Laboratory Technology, Biochemistry, Chemistry or a related field.
• 3–5 years of experience in a GMP Quality Control laboratory.
Technical Skills
• Experience with molecular biology techniques including gel electrophoresis (agarose, CE-SDS and SDS-PAGE), PCR, ELISA, HPLC and spectrophotometry.
• Experience with microbiological testing, including endotoxin, bioburden and growth promotion testing.
• Skilled in aseptic techniques and GMP Quality Control operations.
• Strong knowledge of GMP, Good Documentation Practices and regulatory requirements.
Personal Skills
• Quality-minded, accurate and well organised.
• Proactive team player who can also work independently.
• Confident communicator with a proactive and solution-oriented mindset.
• Flexible in both tasks and working hours when needed.
• Enjoys the energy, ownership and variety that come with a startup environment.