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Laboratory Quality Control Technician II (TB)
CooperSurgical · Alajuela
Description du poste
About the role
CooperSurgical is seeking a Laboratory Quality Control Technician II (TB) to support raw material, intermediate, and finished‑goods testing in a GMP‑compliant environment. The role involves executing a variety of analytical tests, maintaining documentation, and collaborating with internal and external teams to ensure product quality and regulatory compliance.
Key responsibilities
- Perform raw material, in‑process, and final release testing, including bioburden, sterility, filter integrity, pH, osmolality, viscosity, endotoxin, and microbiological assays.
- Record results on inspection forms, maintain organized department files, and notify supervisors of out‑of‑spec results.
- Coordinate external laboratory testing, sample shipment, tracking, and result review.
- Execute environmental monitoring sampling and collaborate with contractors as needed.
- Support equipment qualification, method validation, preventive maintenance, and documentation of maintenance activities.
- Participate in Lean initiatives (5S, Gemba walks) and continuous improvement of SOPs, forms, and lab processes.
- Assist with NCMR, CAPA investigations, and audit preparation.
Required profile
- Intermediate English proficiency; ability to read and write technical documents in English and Spanish.
- Detail‑oriented, proactive, and able to manage time effectively in a fast‑changing environment.
- Team‑oriented with a willingness to train new personnel on specific tests.
Required skills
- Bioburden and sterility testing
- Filter integrity testing
- pH, osmolality, and viscosity measurement
- Endotoxin testing
- Microbiological control and environmental monitoring
- Plate reading and microorganism identification assays
- Good Manufacturing Practices (GMP)
- Good Laboratory Practices (GLP)
- Good Documentation Practices (GDP)
- Familiarity with USP, ACS, Ph. Eur., ASTM standards
- Equipment preventive maintenance
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CooperSurgical
Alajuela