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Laboratory Quality Control Technician II (TB)

CooperSurgical · Alajuela

🇬🇧 English
sterility testing microbiological control environmental monitoring plate reading GMP GLP GDP

Job description

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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Published 2 months ago

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CooperSurgical

Alajuela