- Lilly (Indianapolis, IN)
- …+ Direct or indirect experience with commercialization (Validation, Tech Transfer, CMC, GMP , Quality , and/or HSE) + Demonstrated ability to function in ... manufactured APIs, intermediates and starting materials with safety first and quality always. The role reflects increasing technical complexity and commercialization… more
- Bristol Myers Squibb (Indianapolis, IN)
- …in instrument qualification, calibration, and maintenance activities. + Ensure compliance with GMP regulations, safety guidelines, and quality standards. + Work ... Spectrometry, Alpha Spectrometry, and other analytical methods. + Knowledge of GMP regulations, quality systems, and safety guidelines. + Radiopharmaceutical… more
- Lilly (Indianapolis, IN)
- …Foundry, including benchmarking with other Lilly sites. + Evaluate potential product quality impact for any GMP -related incident (deviation or change control), ... and computer systems (CSQ) within the Foundry and assures compliance with quality systems and current Good Manufacturing Practices (cGMP). This oversight includes… more
- Bristol Myers Squibb (Indianapolis, IN)
- …routine calibration and maintenance of laboratory equipment. Ensure schedule compliance to ensure GMP readiness. + Work with Quality Assurance and Management to ... + Work with RSO and QA to ensure compliance with GMP regulations, safety guidelines, and quality standards (FDA, USP, NRC, EP, and other regulatory agencies as… more
- Otsuka America Pharmaceutical Inc. (Indianapolis, IN)
- …Product Quality (Small molecule)** is responsible for ensuring ** GMP compliance** in the manufacturing packaging, labeling, and distribution of commercial ... packaging activities performed internally and at external vendors, ensuring that quality standards are met and regulatory requirements are maintained throughout the… more
- Lilly (Indianapolis, IN)
- …on quality matters + Ensure regular presence in operational areas to monitor GMP programs and quality systems + Active on local process team, as outlined ... QA Representatives. The QA Representative position is essential for maintaining GMP compliance and providing support during preparation for Pre-Approval / General… more
- Cook Medical (Bloomington, IN)
- …statistics and lean manufacturing principles - Knowledge of medical device quality standards ISO13485/FDA practices, GMP and similar regulated industry ... Introduction (NPI) Engineer will bridge Product Development into Manufacturing Engineering, Quality , and Operations. They will be responsible for configuring and… more
- The Hershey Company (IN)
- …manufacturing environment including the following: Good Manufacturing Practices ( GMP ), Safe Quality Foods (SQF), Autonomous/Preventative Maintenance, ... our team. We hold ourselves to the highest of quality standards. Each bag of Dot's Pretzels tastes as...* * Follow all SOPs to keep consistent product quality * Recognize the different dough textures * Keep… more
- The Hershey Company (IN)
- …manufacturing environment including the following: Good Manufacturing Practices ( GMP ), Safe Quality Foods (SQF), Autonomous/Preventative Maintenance, ... our team. We hold ourselves to the highest of quality standards. Each bag of Dot's Pretzels tastes as...* * Follow all SOPs to keep consistent product quality * Recognize the different dough textures * Keep… more
- Bristol Myers Squibb (Indianapolis, IN)
- …or equivalent.in a GxP-regulated environment, with at least 3 years in auditing or quality assurance. + Experience conducting audits across GMP , GLP, and/or GCP ... RayzeBio aims to be the global leader in radiopharmaceuticals. The Senio r Quality A uditor is responsible for planning, executing, and reporting on internal and… more