- Otsuka America Pharmaceutical Inc. (Boston, MA)
- …operations. + Experience with cGMP manufacturing environments and regulatory requirements ( FDA , EMA, ICH). + Familiarity with process validation principles and CPV. ... be considered for employment. We will also not offer you money to buy equipment, software , or for any other purpose during the job application process. If you are… more
- Charles River Laboratories (Wilmington, MA)
- …interactions, and business development. Proficiency in the use of standard software including Microsoft(R) Excel, Word, PowerPoint, etc. and standard laboratory ... worked on 80% of the drugs approved by the US Food and Drug Administration ( FDA ) in the past five years. We're committed to providing benefits that elevate your… more
- Deloitte (Boston, MA)
- …capabilities to build, deploy, and operate integrated/verticalized sector solutions in software , data, AI, network, and hybrid cloud infrastructure. These solutions ... familiarity with ICH guidelines (ie: ICH Q6A, Q7, Q8, Q9, Q10), FDA /EMA/PMDA regulations, and the structure/content of CMC sections in regulatory submissions (IND,… more
- Fujifilm (Boston, MA)
- …and providing our customers with timely responses. + Works on 3rd party hardware, software , and network related issues that are sold or supported by FUJIFILM. + ... + Comply with all applicable US Food and Drug Administration (US FDA ) medical device regulatory requirements, applicable ISO 13485 standard requirements and all… more
- Sanofi Group (Cambridge, MA)
- …+ Proficiency with Word, PowerPoint, and other corporate standard software required. **Preferred Qualifications:** + Experience counseling pharma/biotech companies ... on FDA or other relevant governmental agencies on healthcare matters **Professional Skills/Attributes:** + Excellent written and oral communication skills + Team… more
- Compass Group, North America (Boston, MA)
- …wellness related programs and initiatives and to ensure compliance with FDA nutrition labeling laws. Responsibilities: *Customizes and implements client sector ... solving skills and outstanding interpersonal skills*Familiarity with nutrition analysis software is preferred*Culinary and/or foodservice experience is preferred*Ability to… more
- Philips (Cambridge, MA)
- …of the product life cycle + Supports Quality Plan design for hardware and Software design and ensure they meet quality and compliance standards for every planned ... a minimum of 3+ years' experience of Quality Engineering experience within FDA regulated, medical device product environments, with a focus in Design… more
- Takeda Pharmaceuticals (Lexington, MA)
- …in a cGMP Engineering role within pharmaceutical, biotechnology, or other FDA regulated industry. + Proficient understanding of instrumentation, and its ... and ASTM 2500 principals + Understanding of AF Analytics and SIMCA Software + Virtualized Server Infrastructure and Networking technologies + Demonstrate competence… more
- Fujifilm (Boston, MA)
- …+ Provide on-going customer support for HCUS MRI products, including: + Software updates. + System upgrades. + Performance troubleshooting follow-up visits. + ... + Comply with all applicable US Food and Drug Administration (US FDA ) medical device regulatory requirements, applicable ISO 13485 standard requirements and all… more
- Charles River Laboratories (Shrewsbury, MA)
- …a professional manner with management, coworkers, and sponsors. Experience with computer software programs is required. PHYSICAL DEMANDS: * Employees must be able to ... proudly supported the development of 86% of the drugs approved by the FDA in 2021. **Equal Employment Opportunity** Charles River Laboratories is an Equal… more