QC Expert

Job Title: QC Expert Duration: 6 monthsLocation: 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 activitiesSupport sample planning and sampling executionReporting technical complaints / adverse events / special case scenarios related to client products within 24 hours of receiptIndividuals should have a good general understanding of chemistry and microbiological laboratory concepts and practices.Key Performance Indicators:Timely completion of trainingTimely and GMP-compliant analysis & documentation of the resultsError rate: Number of OOS (analysis errors) related to the number of analysesWork Experience:3-5 year’s experience in a GMP testing laboratory environment.Good Manufacturing Practices (cGMP)Quality ControlQuality Management SystemsTechnological ExpertiseQuality Control MicrobiologyLaboratory ExcellenceDocumentation ManagementQuality ComplianceSkills & Education:B.S. in the life sciences (Chemistry, Microbiology) or related fieldProblem Solving SkillsCommunication skillsData Integrity