Quality Control Supervisor (Biotechnology)

About the role

MiRXES is seeking a Quality Control Supervisor to lead the QC team in its biotechnology manufacturing operations. The role involves overseeing daily QC activities, ensuring product quality at every manufacturing stage, and maintaining compliance with ISO 13485 and other regulatory standards.

Key responsibilities

• Manage and develop QC staff through training, competency assessments, and performance monitoring.
• Supervise routine QC testing of raw materials, in‑process samples, and finished goods.
• Plan, schedule, and coordinate daily QC operations and ad‑hoc testing projects.
• Maintain laboratory housekeeping, equipment upkeep, document archiving, and reagent inventory.
• Perform data evaluation, draft QC reports, and highlight deviations from SOPs.
• Conduct trend analysis and apply Statistical Process Control (SPC) tools to detect process anomalies.
• Investigate non‑conformances, generate root‑cause analyses, and raise NCRs.
• Support validation and stability studies for new diagnostic products.
• Ensure all laboratory activities comply with ISO 13485 and relevant regulatory requirements.
• Update work instructions and drive continuous improvement of QC workflows.

Required profile

• Diploma, Bachelor or Master degree in Biotechnology, Biochemistry, Analytical Chemistry, Molecular Biology or a related life‑science field.
• Proven experience in a laboratory QC environment, preferably with assay‑based workflows.
• Ability to work independently and collaborate across functions.
• Strong organizational and time‑management capabilities.

Required skills

• Proficiency with quantitative PCR (qPCR) instrumentation.
• Knowledge of Statistical Process Control (SPC) and trend analysis.
• Familiarity with ISO 13485 quality management systems.
• Experience in laboratory testing, validation, and stability studies.
• Competence in data analysis and documentation practices.
• Equipment maintenance and reagent inventory tracking.