Overview

Job Description Job Description QC Associate - Simply BiotechOVERVIEWAre you looking for a new career opportunity with an exciting biotech company?! Then we have got the right team for you! In this role, you are responsible for the duties listed below.Immediate opening for a QC Associate Scientist with a medical device company in San Diego, CA who possesses:Bachelor's degree in a scientific field - Biology, Chemistry, Biotechnology, or Biochemistry preferred1+ years of QC experience1+ years of experience with HPLC and ELISAExperience with GMP documentation, including CAPAs, deviations, and related quality recordsExperience with method development, validation, and transfer highly preferredFULL DESCRIPTION: This position is responsible for performing various analytical and physical testing techniques for the Quality Control team in support of cGMP and development activities. This includes performing periodic testing such as WFI testing, routine testing such as environmental monitoring of classified spaces, analytical testing of drug products, preparing samples using aseptic technique, and participating in animal care and handling as required. This role will work closely with team members to help ensure the quality, safety, and efficacy of products while adhering to quality systems and applicable FDA and/or USDA regulations. The selected candidate will be responsible for:Preparing samples, reagents, and standards for analysisMaintaining accurate and detailed laboratory recordsConducting analytical testing using techniques such as HPLC and ELISAPerforming periodic and routine testing, including WFI system testing and environmental monitoring of classified spacesAnalyzing and interpreting QC dataPreparing technical reports and presenting findings as requiredAssisting with implementation of new analytical methods through method development, optimization, validation protocols, and related activitiesAdhering to standard operating procedures and applicable regulatory and safety requirementsCollaborating with cross-functional teams to support product development and manufacturing activitiesDeveloping and reviewing SOPs and other documentation associated with implementation of the microbiological programPerforming monitoring, inspection, and control of incoming components and materialsSupporting development of specifications and SOPs related to incoming materials and componentsSupporting assays through sample preparation and associated documentationTabulating and analyzing assay resultsWorking with research animals as requiredHandling research animals, including performing body weights, hair removal, monitoring, and related activities as requiredParticipating in laboratory organization and maintenance activities, including glassware washing and solvent preparationPerforming alternate functions and other duties as trained and assignedThe selected candidate will also possess:Bachelor's degree in a scientific field such as Biology, Chemistry, Biotechnology, Biochemistry, or related discipline preferredMinimum of 1 year of biotechnology, pharmaceutical, medical device, or related manufacturing experience1+ years of Quality Control experience preferred1+ years of HPLC experience preferred1+ years of ELISA experience preferredHands-on experience with analytical instrumentationExperience with GMP documentation, including CAPAs, deviations, and related quality recordsBasic understanding of GMP and GLP principlesAwareness of regulatory requirements related to drug development and product lifecycleExperience with method development and method validation preferredMethod transfer experience preferredStrong understanding of analytical techniquesKnowledge of microbiological and scientific terminologyStrong aseptic techniqueExcellent attention to detail and ability to follow protocols preciselyStrong analytical and problem-solving skillsGood written and verbal communication skillsManual dexterity for operating laboratory equipmentAbility to work indepe