Quality Control Associate, Microbiology at Fujifilm

Position OverviewThe QC AssociateMicrobiologyis responsible forexecutingmicrobiologyactivitiesto support Quality ControlFacility andManufacturing operations which includeEnvironmentalMonitoring Performance Qualification (EMPQ) and GMP utilities qualification.The QC Microbiology Associate willbe responsible forperforming environmental monitoring personnel monitoringand microbiological testing to ensure compliance with industry standards and regulations. The successful candidate will work closely with the Quality Control team to support the production process and ensure product quality.Additionallythisposition supports on-site activities related to sample management.Company OverviewAt FUJIFILM Biotechnologies California were driving the future of medicine with the expertise to produce life-changing cell therapies like T-cell and CAR T immunotherapies. Working with pioneering biotech partners our teams manufacture innovative treatments that improve lives. Join us at our advanced Thousand Oaks facility where youll make a tangible impact on groundbreaking therapies. We offer a collaborative flexible workplace and a vibrant culture driven by passion and energywhat we call Genki. If youre ready to reimagine the future of healthcare lets create something extraordinary together. Our campus is in Thousand Oaks California an exceptional place to live with great schools natural beauty outdoor activities and proximity to Los Angeles and Santa Barbara. Fujifilm is globally headquartered in Tokyo with over 70000 employees across four key business segments of healthcare electronics business innovation and imaging. We are guided and united by our Group Purpose of giving our world more smiles. Visit: DescriptionResponsibilities:Environmental/PersonnelMonitoring:Conduct environmental monitoring of controlled areas (e.g. clean rooms).Collect samples fromnon-viableairviableair (active and passive)surface monitoringand personnel monitoring to support routine environmental monitoring in-process environmental monitoring process simulation aseptic operatorqualificationand gowning qualification.Performssamplingandtestingof GMPutilitiessuchascompressedgases.Microbiological Testing:Perform microbiological testing.Ensureall tests are completedin accordance withSOPs and regulatory guidelines.Laboratory Operations and Equipment Maintenance:Conduct routine cleaning and maintenance of laboratory equipment to ensureoptimalperformance.Keep detailed records of equipment maintenance activities and schedules.Generate work ordersfor equipment servicing and repairsas needed.Ensure laboratory cleanliness and compliance with safety standards.Properly handles stores and disposes of hazardous materials according to site procedures.Sample ManagementCoordinates the shipping of isolates for microbial identificationPerforms any combination of sample management tasks includinglabelpreparefor shipping transfer to labs inventory and disposal.Data Management:Accurately record and manage all test results and data.Document execution and data using LIMS orforms.Reviews and verifies sample documents against samples to ensure accuracy and communicate sample information and documentsMaintain databases for tracking trends and ensuring data integrity.Generate reports and communicate findings to relevant stakeholders.Performs document management tasks for sample documentsand logbooks such asuploading ofdata reports/data packets into the document management system (Veeva).Compliance and Quality Assurance:Ensure compliance with Good Manufacturing Practices (GMP) and Good Laboratory Practices (GLP).Support internal audits and regulatory inspections.Assistin the review and revision of SOPs related to microbiology testing.Continuous Improvement:Participate in continuous improvement initiatives within the Quality Control department.Identifyareas for process optimization and implement changes accordingly.Performs special projects as assigned.Requirements (Education&ProfessionalExperience):BachelorsdegreeinmicrobiologyMolecularandCellularBiologyBiochemistryorBiology with0-3years of experience; orAssociate degree with 4 years of direct laboratory experience; or High school diploma with 6 years of experienceQualityControlexperienceinthepharmaceuticalindustrysupportingcGMPmanufacturingincludingsite qualification and utility validation preferred.Directexperienceishighlydesirableinenvironmentalmonitoringpersonnelmonitoringsterilegowningand aseptic process controlin accordance withICHUSPand FDA guidelines.Directexperienceishighlydesirableinregulatoryinspections.Mustpossessexcellentverbalandwrittencommunicationskillsgoodinterpersonalskills.ExperienceincGMP forcelltherapytestingisaplus.Mustbeabletowork incontrolledenvironments requiringspecialgowningPhysical Requirements:Subjecttoextendedperiodsofsittingand/orstandinginalaboratoryandclassifiedroomenvironment..AbilitytouseladderstoreachhighsamplingsitesAbilitytoreachabovetheshoulderandbendtobeabletogownWork is performed in a laboratory environment and includes use of LN2 freezers and lifting/movement of racks of sample boxesShift:Thisrolewillsupporteither4-day 10-hour work scheduleORa5-day 8-hourwork schedule.This role requires working in a flexible and dynamic environmentandit may be necessaryto shift work schedules or work overtime as needed.Salary and Benefits:For California the base salary range for this position is $30.50-38.75 per hour. Compensation for the successful candidate will depend on various factors (e.g. qualifications education prior experience location etc.).Medical Dental VisionLife Insurance401kPaid Time OffLI-#OnsiteEEO InformationFujifilm is committedto providing equal opportunities in hiring promotion and advancement compensation benefits and training regardless of nationality age gender sexual orientation or gender identity race ethnicity religion political creed ideology national or social origin disability veteran status etc.ADA InformationIf you require reasonable accommodation in completing this application interviewing completing any pre-employment testing or otherwise participating in the employee selection process please direct your inquiries to our HR Department ().Required Experience:IC Key Skills Computer,IT Audit,CAD CAM,ABAP,Exterior Designing,HR Operations Employment Type : Unclear Department / Functional Area: Quality Control Experience: years Vacancy: 1 Hourly Salary Salary: 30 - 38