QC Expert

Location: Carlsbad, California (Onsite)

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 Quality Compliance Skills &

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