Changing lives. Building Careers. Joining us is a chance to do important work that creates change and shapes the future of healthcare. Thinking differently is what we do best. To us, change equals opportunity. Every day, our colleagues are challenging what's possible and making headway to innovate new treatment pathways to advance patient outcomes and set new standards of care. To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. + Ensure compliance with all company policies and procedures and appropriate regulations, including FDA and ISO 9001, ISO 13485, CMDR and the Medical Device Directive. + Considered a subject matter expert (SME) for test method(s) executed in the laboratory. + Perform and document in-house microbiological testing on all in-process and finished products to comply with acceptance requirements. + Perform endotoxin (LAL) testing, Bioburden analysis, growth promotion, gram staining, identification of microorganisms, and other microbiological testing. + Perform and document environmental monitoring of cleanrooms, including non-viable particulate, active viable airborne, and viable surface contact sampling. + Sample utility systems including WFI, steam, and compressed air. + Provide gowning training and qualification to operators, cleaners, and other essential staff. + Manage sample shipment and processing with third party labs. + Maintain GMP/GLP laboratory notebooks and documentation relevant to the duties and responsibilities assigned. + Maintain laboratory instrumentation and report any equipment issues to Supervisor. + Complete laboratory Alert/Action (AA) notifications and Out-of-Specification (OOS) investigations. + May be responsible for representing the department in cross functional meetings. + Assist in the review of test data and report any deviations to Supervisor. + Train and provide guidance to team members in the Microbiology department. + Analyze trend data and create trending reports. + Create/Revise Standard Operating Procedures (SOPs). + Responsible for writing investigations in order to identify root causes and recommend corrective actions to support and improve production. Drive assigned CAPAs to closure. + Handle and dispose of biohazard material in compliance with OSHA and Standard Operating Procedures. Perform other related duties as required Integra LifeSciences is an equal opportunity employer, and is committed to providing equal employment opportunities to all qualified applicants and employees regardless of race, marital status, color, religion, sex, age, national origin, sexual orientation, physical or mental disability, or protected veteran status. This site is governed solely by applicable U.S. laws and governmental regulations. If you'd like more information on your rights under the law, please see the following notices: EEO Is the Law (https://www.eeoc.gov) | EOE including Disability/Protected Veterans (https://www.eeoc.gov/eeoc/publications/ada\_veterans\_employers.cfm) Integra LifeSciences is committed to provide qualified applicants and employees who are disabled veterans or individuals with disabilities with needed reasonable accommodations in accordance with the ADA (https://www.eeoc.gov/eeoc/publications/fs-ada.cfm) . If you have difficulty using our online system due to a disability and need an accommodation, please email us at careers@integralife.com or call us at 855-936-2666. Integra - Employer Branding from Integra LifeSciences on Vimeo (https://player.vimeo.com/video/265760526)