Technician QC Microbiology

ph3Aperçu /h3 pbSummary /b /p pThe QC Microbiology Technician performs microbiology activities to support production and release of drug substance and drug product, including sterility testing of aseptically filled drug product (DP) using an isolator, as well as environmental and utilities monitoring and control in a GMP environment. In addition to routine testing, the QC Microbiology Technician contributes to microbiology method verifications/validations (e.g., Bioburden, LAL), performs review of data and documentation, and actively contributes to continuous improvement, laboratory automation initiatives, and laboratory investigations including root cause analysis. He/she also authors and maintains analytical and QC procedures and provides technical support to other team members. /p pbKey responsibilities /b /p ul liPerforms QC analysis to support production release of drug substance (Bioburden, LAL), ensuring right-first-time execution and documentation. /li liPerforms sterility testing of aseptically filled drug product (DP) using an isolator to support DP batch release, ensuring compliant aseptic manipulations, right-first-time execution, and accurate GMP documentation. /li liPerforms sampling and testing for environmental monitoring and utilities control (PV, PNV, Bioburden, LAL, TOC), including scheduling and prioritization when needed. /li liEnsures adherence to GMP, data integrity requirements, safety rules, and internal quality standards. /li liExecutes microbiology method verification/validation activities (Bioburden/LAL and related methods): preparation, execution, documentation, and closure. /li liPerform thorough review of analytical raw data, calculations, records and reports, including second-person review as applicable, ensuring completeness, traceability, data integrity, compliance, and timely reporting of results. Contributes actively to laboratory investigations, including structured root cause analysis and definition of robust CAPAs. /li liCollaborates cross-functionally (Production, QA, Engineering, Validation, other QC functions) to support investigations and prevention of recurrence. /li liParticipates in improvement projects to increase lab efficiency, quality, and compliance. /li liContributes to laboratory digitalization/automation initiatives. /li liAuthors, reviews and maintains SOPs, Work Instructions, and other QC documentation. /li liSupports change control activities related to methods/equipment/procedures. /li liSupports management of QC consumables, reagents and standards. /li liSupports maintenance/calibration of equipment. /li liActs as a role model for GMP behaviors, data integrity, and business ethics. /li /ul pbEducation and Experience /b /p ul liDegree in Microbiology (CFC or higher degree) with at least 5 years of experience in biotech, pharmaceutical environment, including QC Microbiology in a GMP setting. /li liProven hands-on experience with Bioburden and LAL testing, environmental monitoring and utilities control. /li liProven hands-on experience in sterility testing of aseptically filled drug product (DP) using an isolator, including aseptic manipulations, isolator operation, and associated GMP documentation. /li liStrong knowledge of microbiology testing in GMP and of method verification/validation/transfer principles. /li liExperience in data review (raw data, logbooks, calculations, reports) and in applying data integrity principles. /li liExperience supporting deviation investigations, root cause analysis, and CAPA implementation. /li liHigh autonomy and accountability; able to prioritize, anticipate issues, and propose solutions. /li liForce of proposal / continuous improvement mindset; comfortable driving improvements and supporting automation/digitalization. /li liExcellent team spirit and communication; able to collaborate cross-functionally. /li liFrench: Native or Fluent /li liEnglish: Good knowledge /li liKnowledge of most common office software. /li /ul pbWork conditions /b /p ul liWork on weekends and outside standard working hours may be required. /li /ul /p #J-18808-Ljbffr