- Novo Nordisk (Bloomington, IN)
- …work tasks assigned + Executes complex with high quality + Knowledge of cGMP , ICH, FDA, EMA regulations or guidelines + Intermediate understanding of pharmaceutical ... laboratory and/or production operations + Capable of learning unfamiliar principles or techniques with training + Prior experience leading deviation investigations using root cause analysis tools + Champion change control and corrective / preventative actions… more
- University of Pennsylvania (Philadelphia, PA)
- …health and wellness programs and resources, and much more. Posted Job Title Senior Research Investigator (Department of Pharmacology) Job Profile Title Research ... Investigator , Senior Job Description Summary The functions of this position...and accurate lab notes + Develop new methods to cGMP produce nucleoside-modified mRNA + Develop new methods to… more
- Curia (Albuquerque, NM)
- …exceptional technical accuracy and thoroughness in all reporting. In this senior -level position, the Investigator collaborates with cross-functional teams to ... Quality Deviation Investigator III in Albuquerque, NM Summary: The Quality...culture of quality and compliance across the organization, advising senior leadership on strategic improvements, and ensuring alignment with… more
- Curia (Albuquerque, NM)
- Quality Deviation Investigator II Curia provides global contract research and manufacturing services to the pharmaceutical and biotechnology industries. Join our ... 401k program + Learning platform + And more! Summary: The Quality Deviation Investigator (QDI) II is responsible for leading investigations to ensure the written… more
- Novo Nordisk (Bloomington, IN)
- …include technical data review, training, instrument maintenance, lead investigator , and laboratory information management system (LIMS) administration. These ... products and stability samples, while adhering to SOPs and working in a cGMP compliant environment. The position will analyze and interpret results in written and… more
- Eurofins (Columbia, MO)
- …necessary to perform laboratory assignments. + May serve as study director, principal investigator , or project leader for GLP and CGMP studies. May assist ... methods, etc.). Completes complex work for research and development, CGMP and GLP studies and documents and reports data...with, and knowledge of, regulatory guidelines and company SOPs ( CGMP , GLP) is required. + Good organizational skills and… more
- Lilly (Plainfield, IN)
- …determined to make life better for people around the world. The Senior Operations Associate supports the North American Logistic Operations (NALO) organization, ... events and drive implementation of appropriate countermeasures (Trackwise Lead Investigator and Change Owner). + Ensure appropriate training curricula are… more
- Mitsubishi Chemical Group (Jersey City, NJ)
- …researching on real-world evidence, and creating hope for all facing illness. The Senior Manager, Clinical Supplies will manage the complete clinical supply chain of ... for effectively managing the clinical supply chain in accordance with study protocols, cGMP , EU GMP, GCP, ICH, FDA and any applicable international, federal and/or… more
- System One (San Francisco, CA)
- Title: Senior Manager, QA Operations Location: The position will be remote, with a preference of CA residency. Travel: Up to 25% travel may be necessary in order to ... effectively oversee CDMO's POSITION SUMMARY Senior Manager, QA Operations. + In this role you...* Comprehensive working knowledge of FDA, ICH and international cGMP regulations, guidelines, and application to drug development *… more
- Novo Nordisk (Bloomington, IN)
- …include technical data review, training, instrument maintenance, lead investigator , and laboratory information management system (LIMS) administration. These ... data integrity and ensure compliance with company SOP's, specifications, as well as cGMP , ICH, FDA, EMA regulations or guidelines + Leads regulatory and client… more
- Olon Ricerca Bioscience LLC (OH)
- …is desirable Specific Skill and Requirements: + Routinely assumes the primary investigator /project leader role + Analyzes synthetic routes and processes provided by ... as required to meet client goals + Has a working knowledge of cGMP regulations, process scale-up requirements, and process chemistry techniques + Has a working… more