QC Expert

Spectraforce Technologies, Inc.; Carlsbad (CA); On-site; USD 70,000 - 95,000; Part time

Job summary

Spectraforce Technologies, Inc. is seeking a QC Expert in Carlsbad, CA to apply chemistry lab skills, perform analytical testing, and ensure SOPs and compendia compliance.

The role emphasizes data integrity and regulatory compliance within a GMP environment. The position requires hands-on microbiological QC, HPLC/UPLC operation, and collaboration with cross-functional teams to support site qualification, validation activities, and timely issue resolution.

Qualifications

• 3–5 years of experience in a GMP testing laboratory environment.
• Good Manufacturing Practices (cGMP) experience.
• Quality Control
• Quality Management Systems
• Technological Expertise
• Quality Control Microbiology
• Laboratory Excellence
• Documentation Management
• Quality Compliance

Responsibilities

• Ensure all activities comply with cGxP, including data integrity review and approval of analytical data/tests (analytical release).
• Review and approval of analytical tests (analytical release).
• Perform HPLC/UPLC analyses (Empower software experience preferred).
• Conduct microbiological QC: testing of materials, utilities, environmental and personnel monitoring; support site qualification and validation activities.
• Support sample planning and sampling execution.
• Report technical complaints/adverse events/special cases within 24 hours of receipt.
• Maintain a good general understanding of chemistry and microbiological lab concepts.
• Monitor KPIs: timely training, GMP-compliant analysis & documentation, and low OOS rates.

Skills

Problem Solving

Communication

Data Integrity

Education

B.S. in Life Sciences

Tools

HPLC

UPLC

Empower

Job description

Position Title: QC Expert

Work Location: Carlsbad, CA 92008

Assignment Duration: 6 months

Work 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.

Work Arrangement: Onsite

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

Position Summary

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.

Key Responsibilities

• 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 the organization's 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
• Communication skills
• Data Integrity