- Legend Biotech USA, Inc. (Raritan, NJ)
- …biochemical and microbiological concepts is required.Experience with aseptic processing in ISO 5 clean room and biosafety cabinets is preferred.Ability to quickly ... process complex information and often make critical decisions with limited information.Ability to handle multiple priorities on a daily basis while being flexible and responsive to frequently shifting priorities.Proficient in applying process excellence tools… more
- Twist BioScience (South San Francisco, CA)
- …gene synthesis solutions and support broader product adoptionFollow regulatory and ISO 13485 requirementsWhat You'll Bring to the TeamTrack record of success ... defining and launching products in the research tools marketplace with a deep knowledge of synthetic DNA preferredMust speak DNAUnderstanding of gene synthesis technologies, workflows including current and future applicationsProven ability to influence… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …of measure, using whole numbers, common factions, and decimals,Aseptic processing in ISO 5 clean room and biosafety cabinets.Knowledge of cGMP regulations and FDA/EU ... guidance related to manufacturing of cell-based products as well as knowledge of Good Tissue Practices.Great attention to detail and ability to follow the procedures.The candidate must be highly organized and capable of working in a team environment with a… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …in a Quality Control setting is preferred.Experience with aseptic processing in ISO 5 clean room and biosafety cabinets is required.Knowledge of cGMP regulations ... and FDA/EU guidance related to manufacturing of cell-based products is required.Knowledge of Good Tissue Practices is required.Detailed knowledge of CAR-T QC test methods and related equipment is preferred.Excellent written and oral communication skill are… more
- Twist BioScience (South San Francisco, CA)
- …such as LIMsExperience working within) controlled or regulated environments (eg, ISO 13485, CLIA, etc.), with involvement in documentation, validation planning, or ... audit preparationFamiliarity with eCommerce platforms and Business Applications such as Salesforce.com and SAPFamiliarity with development and code management systems like Jira and GitHub.Experience in working in a scientific or biotech environmentPMP… more
- ALPCO (CA)
- …principles, diagnostics, and instrumentation. Familiarity with quality management systems ( ISO 13485). Strong organizational skills: ability to work independently ... and prioritize in a customer-driven environment. Excellent communication skills (oral, written, presentation). Willingness to travel 70–80% domestically, with occasional international travel for training Strong analytical problem-solving and multitasking… more
- Twist BioScience (South San Francisco, CA)
- …user manuals.Ensure software complies with applicable regulatory standards (eg, FDA, ISO 13485, if applicable).Contribute to research and development efforts for ... next-generation instruments.Evaluate new technologies, frameworks, and methodologies to improve instrument performance and usability.Work closely with scientists, lab personnel, manufacturing teams, and field service engineers to gather feedback and implement… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …biochemical and microbiological concepts is required.Experience with aseptic processing in ISO 5 clean room and biosafety cabinets is preferred.Experience with ... collaborating and communicating effectively with service providers, suppliers, and CMO/CDMOsAbility to handle multiple priorities on a daily basis while being flexible and responsive to frequently shifting priorities.Proficient in applying process excellence… more
- ValSource, Inc. (Durham, NC)
- …of Industry guidelines (ISPE, PDA), US and international regulations (FDA, ICH, ISO , EU) for validation of GMP facilities. Proficiency with Microsoft office ... including Word, Excel, and PowerPoint. Microsoft Project and Visio a plus. ExperiencePreferred Commissioning, Qualification and Validation (CQV) experience in Pharmaceutical, Biotech, Medical Device or related GMP manufacturing environment preferred. Recent… more
- Comau LLC (Southfield, MI)
- …and modified tooling Ensure compliance with applicable standards such as OSHA, ANSI, ISO 12100, ISO 13849 and local regulations. Performing Safety Analysis ... during all project phases, participate in tooling design reviews giving continuous feedbacks to the Project Team Validate guarding, interlocks, lockout points, pinch-point protection, emergency stop etc. On site checks. In order to verify the correct line… more
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