QC Expert

TriOptus LLC; Carlsbad (CA); Presencial; USD 70 000 - 110 000; Tempo integral

Resumo da oferta

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.

Qualificações

• 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.

Conhecimentos

Chemistry knowledge

Microbiology concepts

Data integrity

Ferramentas

HPLC/UPLC

Empower software

Descrição da oferta de emprego

Note: The external will be working with Radioactive materials, chemicals and dealing with various microorganisms.

Shift: Shift hours are expected to be 8AM to 8PM {Sunday to Tuesday and every other Wednesday} OR {Every other Wednesday and Thursday to Saturday}.

Periodic mandatory overtime may be necessary to ensure process continuity and completion.

Job Description:

This role utilizes chemistry laboratory skills to test and measure product or materials while ensuring that analysis is performed according to established Standard Operating Procedures (SOPs), Analytical Methods and current Compendia.

Major Accountabilities:

• Ensure all activities in compliance with cGxP, incl. data integrity review and approval of analytical data / tests (analytical release)
• Review and approval of analytical tests (analytical release)
• HPLC/UPLC (Empower software experience preferred)
• Microbiological QC, 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
• Reporting technical complaints / adverse events / special case scenarios related to client products within 24 hours of receipt
• Individuals should have a good general understanding of chemistry and microbiological laboratory concepts and practices.

Key Performance Indicators:

• Timely completion of training
• Timely and GMP-compliant analysis & documentation of the results
• Error rate: Number of OOS (analysis errors) related to the number of analyses

Work Experience:

• 3-5 year’s experience in a GMP testing laboratory environment.
• Good Manufacturing Practices (cGMP)
• Quality Control
• Quality Management Systems
• Technological Expertise
• Quality Control Microbiology
• Laboratory Excellence
• Documentation Management