QC Expert

Job Title: QC Expert
Location: Carlsbad, CA
Duration: 06 months
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

Communication skills

Data Integrity

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