- Novo Nordisk (Bloomington, IN)
- …ordering, and stocking supplies + Stages materials/components for use within cGMP Quality Control lab + Accurately completes routine and preventive maintenance ... room procedure, aseptic technique, and general lab equipment experience + cGMP , Good Documentation Practices (GDP), or Good Laboratory Practices (GLP) knowledge… more
- Novo Nordisk (Bloomington, IN)
- …personnel indirectly and directly involved in GMP operations pertaining to cGMP compliance, internal procedures, regulatory requirements and industry best practices ... + Prior experience working in and/or supporting aseptic operations in a cGMP environment as it relates to cleaning and sanitization, regulatory (worldwide),… more
- Lilly (Lebanon, IN)
- …responsibilities include aligning cross functional teams to ensure the seamless start-up of cGMP production as well as monitoring of activities for Right First Time ... manufacturing performance using appropriate performance metrics and targets. + Ensure cGMP readiness of manufacturing areas for start-up and process qualification… more
- Lilly (Indianapolis, IN)
- …Compliance:** Ensure adherence to current regulatory requirements, including cGMP standards, OSHA regulations, and environmental sustainability goals. Support ... + Experience in device assembly and/or packaging. + Knowledge of cGMP requirements in medical device manufacturing. + Understanding of basic requirements… more
- Fujifilm (Indianapolis, IN)
- …lead/ and Head of site PM as required. + Compliance: Keep current on cGMP , regulatory and quality requirements that impact Company manufacturing. + All other job ... + Mastery knowledge in Project/Program Management. + Mastery knowledge of cGMP manufacturing operations and strong understanding of global manufacturing processes. +… more
- Biomat USA, Inc. (South Bend, IN)
- …Clinical Laboratory Improvement Amendments (CLIA), Current Good Manufacturing Practice ( cGMP ) and internal company procedures. * Supervise donor selection, plasma ... regulations, with FDA approved Standard Operating Procedure Manual, OSHA, CLIA and cGMP . * Attend all required training sessions, staff meetings, etc. * Ensures… more
- Lilly (Lebanon, IN)
- …or formal discussion (crew meetings, safety representative). + Know and follow cGMP practices, safe work habits, plant dress code, hygiene standards, and ... (desktop software) are required. + Solid understanding of FDA guidelines and cGMP requirements. + Excellent interpersonal, written and oral communication skills +… more
- Biomat USA, Inc. (Merrillville, IN)
- …test results. * Assists the Quality Systems Manager to ensure that cGMP regulation, SOPs and regulatory requirements are followed. Duties include: Under the ... the Quality Associate role in a proficient manner. Has a basic understanding of cGMP and quality systems. Is able to spend hours sitting and reviewing documentation… more
- Bristol Myers Squibb (Indianapolis, IN)
- …with RayzeBio policies, standards, procedures and global current Good Manufacturing Practice ( cGMP ). The Senior Manager provides Quality support and oversight for QC ... clinical/commercial manufacturing is desired. . Knowledge of US, EU and rest-of-world cGMP regulations and guidance. . Knowledge and proven experience in FDA, EMA,… more
- Novo Nordisk (Bennington, IN)
- …and training necessary for a compliant Good Manufacturing Practice ( cGMP ) biomanufacturing environment. Schedule: Nights 6pm-6:30am 2/2/3 Relationships Reports to ... the starting point to acquiring skills and training required for a cGMP biomanufacturing environment. The Manufacturing Operator is responsible for the purification… more