- Medline Industries, Inc. (Northfield, IL)
- …or engineering background. Certification / Licensure CISS (Certified Industrial Sterilization Specialist ). Work Experience At least 4 years of direct experience ... working in the industrial sterilization of healthcare products. This must include EO cycle development and validation, radiation dose setting, and moist heat experience. Experience supporting sterilization topics to regulators (eg FDA, ISO NB) during audits… more
- Medline Industries, Inc. (Chandler, AZ)
- …Lead advanced, technical sterilization support for sterilization related projects among various Medline product divisions, sterilization facilities, and contract ... laboratories to maintain compliance to regulations and industry standards (eg 21 CFR Part 820, ISO11135, ISO11137, ISO13485 etc.). Apply engineering, microbiology and chemistry principles to develop, support and troubleshoot sterilization processes and… more
- Medline Industries, Inc. (Cleveland, OH)
- …Lead advanced, technical sterilization support for sterilization related projects among various Medline product divisions, sterilization facilities, and contract ... laboratories to maintain compliance to regulations and industry standards (eg21 CFR Part 820, ISO11135, ISO11137, ISO13485 etc.)Apply engineering, microbiology and chemistry principles to develop, support and troubleshoot sterilization processes and challenges… more
- Actalent (Brownsburg, IN)
- Sterility Assurance Specialist - Brownsburg, IN INTERESTED IN THIS ROLE? Apply and reach out TODAY directly to Grace Williams for immediate consideration ... for the commercialization of its products. Actively seeking a Lead Microbio Sterility Assurance Specialist who is willing to take responsibility and grow… more
- Danaher Corporation (Muskegon, MI)
- …internal training for Microbiology; Responsible to investigate microbiological and sterility failures. + Responsible to create and maintain Contamination Control ... Strategy at site level. Including implementing and maintaining a Cleanliness and Hygiene Program; Design transfer (SOPs creation) for routine monitoring, equipment requalification and training for microbiological controls. Maintain and sustain requalification… more
- Regeneron Pharmaceuticals (East Greenbush, NY)
- …the planning, coordinating, and facilitating of activities required to maintain sterility assurance throughout the development and commercialization of ... as required + Identify continuous improvement opportunities + Present data related to sterility assurance and microbial control to leadership + Maintain required… more
- Regeneron Pharmaceuticals (East Greenbush, NY)
- …the planning, coordinating, and facilitating of activities required to maintain sterility assurance throughout the commercialization of Regeneron's drug ... support the manufacturing of sterile drug product, such as knowledge in sterility sampling and testing, single-use redundant filtration (SURF), and good isolator… more
- Johns Hopkins University (Baltimore, MD)
- …optimization. + Function as an active member of the Quality Assurance Team Lead: Maintenance log tracking, inventory monitoring, distribution tracking, technology ... transfer agreement monitoring, sterility testing, equipment maintenance agreement upkeep, investigator billing, weekly...regular quality tracking reports and present to the Quality Assurance Team and CAP compliance committee. + Maintain clinically… more
- Medtronic (PR)
- …solve problems, make progress, and deliver meaningful innovations. The **Senior Director, Sterility Assurance ** will be responsible for all strategy, safety, ... products. **Nice to Have** . A current certified sterilization specialist designation with AAMI in at least one modality....active participant in the development of industry standards impacting sterility assurance in pharma or medical devices… more
- MD Anderson Cancer Center (Houston, TX)
- …during processing of products to ensure to ensure the integrity, viability and sterility of cellular products until final infusion to the patient. Must adhere to ... laboratory records and prepare reports for review by laboratory directors, quality assurance and physicians. 1. Coordinate and manage supply inventory required for… more
- Bon Secours Mercy Health (Greenville, SC)
- …as determined by the facility. The Lead will act in accordance to sterility per the Association for the Advancement of Medical Instrumentation (AAMI), The Joint ... cards, supply ordering and management. Accurately maintains comprehensive quality assurance standards related to sterilization and infection control. + Operates… more
- Tufts Medicine (Boston, MA)
- …Technologist (RT) Certification **OR** ; Registered Cardiovascular Electrophysiology Specialist (RCES) Certification. Basic Cardiac Life Support (BCLS) Certification ... (6) months of hire. **Preferred** **Qualifications:** Registered Cardiovascular Electrophysiologist Specialist (RCES) Certification. **Duties and Responsibilities:** The duties and… more