Laboratory Quality Control Specialist – TB

About the role

The Laboratory Quality Control Specialist (TB) is responsible for executing and overseeing analytical testing of raw materials, intermediates, and finished products to ensure compliance with regulatory standards. This position works within a GMP/GLP environment, supporting product release and continuous improvement of laboratory operations.

Key responsibilities

• Perform raw material, in‑process, and final product testing including bioburden, sterility, filter integrity, pH, osmolality, viscosity, endotoxin, and microbiological assays.
• Record results on inspection forms, maintain accurate files, and notify supervisors of out‑of‑specification results.
• Coordinate external testing, sample shipment, and result tracking.
• Execute environmental monitoring sampling and collaborate with contractors when needed.
• Maintain laboratory equipment, perform preventive maintenance, and ensure compliance with GMP, GLP, GDP, USP, ACS, Ph. Eur, and ASTM standards.
• Support Lean initiatives, inventory management, training of new personnel, and continuous improvement projects.
• Assist with NCMR, CAPA investigations, and audit preparations.

Required profile

• Minimum 4 years of experience in a regulated medical device or pharmaceutical manufacturing environment.
• Proficient in English (advanced) and able to read technical documents in Spanish.
• Strong knowledge of GMP, GLP, GDP; ISO 17025 knowledge is a plus.
• Detail‑oriented, effective time manager, proactive team player with problem‑solving abilities.

Required skills

• Bioburden and sterility testing
• Filter integrity, pH, osmolality, viscosity, endotoxin assays
• Microbiological environmental monitoring and plate reading
• Aseptic technique and operation of manual, semi‑automated, and automated laboratory equipment
• Preventive maintenance of lab instruments
• Compliance with GMP, GLP, GDP, USP, ACS, Ph. Eur, ASTM standards
• Knowledge of ISO 17025 (preferred)