GMP QC Microbiology & Analytics Specialist

TriOptus LLC; Carlsbad (CA); Presencial; USD 70.000 - 110.000; Jornada completa

Descripción de la vacante

TriOptus LLC in California is seeking a skilled QA/QC analyst to join our GMP testing team. You will apply chemistry laboratory techniques, conduct HPLC/UPLC analyses, and ensure data integrity in every step of analytical testing.

Responsibilities include review and approval of analytical data, microbiological QC, environmental and personnel monitoring, and supporting site qualification and validation activities. Candidates should have 3–5 years in a GMP lab and strong documentation practices.

Formación

• 3–5 years of experience in a GMP testing laboratory environment.
• Solid understanding of cGMP and QA/QC processes.
• Strong documentation practices and data integrity auditing.

Responsabilidades

• Ensure activities comply with cGxP and approve analytical data.
• Review and approve analytical tests (analytical release).
• Perform microbiological testing of materials and utilities; environmental and personnel monitoring.
• Provide expert support for site qualification and validation activities.
• Support sample planning and sampling execution.
• Report technical complaints / adverse events / special cases within 24 hours.

Conocimientos

Chemistry knowledge

Microbiology concepts

Data integrity

Herramientas

HPLC/UPLC

Empower software

Descripción del empleo

TriOptus LLC in California is seeking a skilled QA/QC analyst to join our GMP testing team. You will apply chemistry laboratory techniques, conduct HPLC/UPLC analyses, and ensure data integrity in every step of analytical testing.

Responsibilities include review and approval of analytical data, microbiological QC, environmental and personnel monitoring, and supporting site qualification and validation activities. Candidates should have 3–5 years in a GMP lab and strong documentation practices.