- Merck (West Point, PA)
- **Job Description** The incumbent will be part of the Microbiological Quality & Sterility Assurance organization, a Quality Assurance group that has global ... strategy to drive compliance and continuous improvement in the network. Delivers support for regulatory inspections and responses. The incumbent must be experienced… more
- Cordis (Irvine, CA)
- …+ Support drug coating and combination product processes, including microbiological risk assessment for drug substances, excipients, and coating operations. + ... Manager** provides strategic leadership and technical oversight for all microbiological activities supporting the manufacture of Selution SLR (TM) drug-eluting… more
- Unither Pharmaceuticals (Rochester, NY)
- …JOB SUMMARY: With limited supervision, develops, qualifies, and troubleshoots microbiological analysis for stability, finish product and raw material release, ... train laboratory personnel. ESSENTIAL FUNCTIONS / RESPONSIBILITIES: Manufacturing Operational Support Collaborate with other departments on investigations to determine… more
- Bausch + Lomb (Clearwater, FL)
- …with cGMP, ISO 13485, and FDA regulations. + Oversee microbiological testing programs, including bioburden, endotoxin, sterility, and microbial identification. ... and laboratory excellence for the site. + Lead and coordinate microbiological risk assessments for laboratory operations, ensuring alignment with corporate quality,… more
- Parexel (Topeka, KS)
- …certification + Disinfection studies where appropriate + Critical thinking with data MICROBIOLOGICAL PRODUCT ANALYSIS + Analyze samples and compile meaningful data + ... + Ad Hoc work + Rotational on-call assignments for responding to alarms MICROBIOLOGICAL ACTIVITIES Include (but not limited to): + Receive, verify & Log in… more
- Bristol Myers Squibb (Summit, NJ)
- …and/or supports change controls, deviations, CAPAs within the eQMS system. + Support equipment, facility, and microbiological method qualifications. + Ensure the ... highly critical role and is responsible for managing Sterility Assurance which provides support to the CAR T manufacturing site. This role is responsible for… more
- Curia (Albuquerque, NM)
- …conducts and/or delegates, the final review and approval of environmental and microbiological test results including contract labs to support lot disposition ... serve as the subject matter expert on contamination control and microbiological testing of parenteral drug products. This role involves significant participation… more
- Actalent (Irvine, CA)
- …work closely with cross-functional teams to maintain robust sterilization and microbiological control programs that ensure product quality and patient safety. ... standards. + Update, revise, and improve procedures related to sterilization, microbiological testing, and environmental monitoring. + Serve as a steward for… more
- ADM (Decatur, IL)
- …IL)** Full Time, non-Exempt position **Position Summary:** + Perform hands on microbiological testing of samples for the Microbiology Laboratory that services 20+ ... Accurately, interpret, record, and report analytical results in a timely matter. + Support and comply to all applicable FDA, GMP, USP, Biosafety, and OSHA… more
- Gilead Sciences, Inc. (Foster City, CA)
- …Control. This individual provides strategic leadership and oversee daily microbiological operations. Responsibilities include leading the microbiology QC team ... Lead the development and implementation of end-to-end Quality Control (QC) microbiological strategies for Gilead's biologics and small molecules products, including… more
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