Responsible for supporting QC testing for in-process, final product, stability Perform routine testing of in-process, final product and stability samples. Perform environmental/facilities monitoring and microbiological testing. May perform testing for method transfer/ verification/ validation. Perform data verification, data review and review of GMP documentation for general methods. May perform document revision, project, CAPA and deviation/ investigation related tasks and/ or continuous improvement efforts. Train analysts on general job duties. Perform other tasks as assigned. Reporting Relationship * This position will report to QC management. Qualifications Specific Knowledge, Skills, Abilities: Ability to accurately and completely understand, follow, interpret and apply Global Regulatory and cGMP requirements. Ability to communicate effectively with peers, department management and cross-functional peers. Ability to work in a fast-paced team environment, meet deadlines, and prioritize work. Ability to accurately and completely understand, follow, interpret and apply Global Regulatory and cGMP requirements. Knowledge of LIMS, ELN and laboratory data analysis systems preferred. Problem-solving ability/mentality, technically adept and logical. Ability to communicate effectively with peers, department management and cross-functional peers. Experience with writing technical documents preferred. Ability to work in a fast-paced team environment, meet deadlines, and prioritize work Bachelor's degree or equivalent required, preferably in science. Netherlands: MLO level 4 required. 2+ years of relevant microbiological testing or QC experience or equivalent combination of education and experience, preferably in a regulated environment. Demonstrated experience with microbiological techniques