QC Expert

eTeam; Carlsbad (CA); On-site; USD 48,000 - 51,000; Full time

Job summary

eTeam in Carlsbad, CA is seeking a GMP-lab QC specialist to perform analytical testing of products and materials in accordance with SOPs and regulatory standards.

The role requires 3–5 years in a GMP testing lab, a B.S. in life sciences, and hands-on experience with HPLC/UPLC and microbiology, plus a strong focus on data integrity and precise documentation.

Qualifications

• 3–5 years of experience in a GMP testing laboratory environment.
• Knowledge of cGMP and quality management systems.
• Experience in quality control and microbiology.
• Strong documentation management and data integrity practices.

Responsibilities

• Ensure compliance with cGxP and review/approve analytical data for release.
• Review and approve analytical tests for release.
• Operate HPLC/UPLC systems; Empower software experience preferred.
• Perform microbiological testing of materials and utilities; monitor environment and personnel.
• Support sampling planning and execution.
• Report technical complaints/adverse events within 24 hours of receipt.
• Apply sound chemistry and microbiology concepts to daily work.

Skills

GMP testing experience

Data integrity

Analytical problem solving

Documentation management

Education

B.S. in life sciences (Chemistry, Microbiology)

Tools

HPLC/UPLC

Empower software

Job description

Pay Range: $(35.00 – 37.00)/hr on W2 all-inclusive without benefits

Shift Schedule: 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 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 years 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
• Quality Compliance

Skills & Education:

• B.S. in the life sciences (Chemistry, Microbiology) or related field
• Problem Solving Skills
• Data Integrity

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