- System One (Devens, MA)
- …investigation activities to ensure strict compliance with GMP standards and regulatory expectations. Key Responsibilities: + Perform GMP walkthroughs and provide QA ... records; support lot disposition + Participate in internal audits, FDA inspections, and client audits + Support quality systems,...5-7 years, or MS with 3-5 years in an FDA -regulated industry + Minimum 7+ years in GMP QA… more
- Takeda Pharmaceuticals (Boston, MA)
- …R&D imports and exports are conducted in accordance with the rules and regulatory requirements of Customs and other applicable governmental agencies in the affected ... Government Laws and Regulations. This includes US Customs and Border Protection, USDA, FDA , Fish Wildlife, Public Health, Bureau of Industry and Security, DEA, FAA… more
- J&J Family of Companies (Danvers, MA)
- …as the subject matter expert (SME) for process validation, ensuring alignment with FDA 21 CFR Part 820, ISO 13485, and other applicable regulations and standards. ... validation procedures, tools, and templates based on industry trends and regulatory changes. Required Qualifications: + Bachelor's or Master's degree in Engineering,… more
- Charles River Laboratories (Wilmington, MA)
- …his/her supervisor. + Provide quality assurance monitoring of projects to assure regulatory compliance of complex and critical computer systems at designated sites, ... of the computer validation training programs and present training in regulatory requirements for validation, maintenance, and operation of computer technologies. +… more
- Catalent Pharma Solutions (Chelsea, MA)
- …+ Participated in managing and fronting Regulatory Inspections from both EU and US Regulatory agencies such as MHRA, IBM, FDA , USDA; + Ability to work under ... establish, document and monitor Quality standards and requirements that meet Catalent, Regulatory and Customer requirements; + To ensure that the site complies with… more
- Charles River Laboratories (Wilmington, MA)
- …an experienced professional with expertise in establishing effective scientific and regulatory strategies to advance new medicines through the various stages of ... products. Successful individuals have knowledge of domestic and international regulatory expectations and requirements; and can provide intellectual input in… more
- Takeda Pharmaceuticals (Lexington, MA)
- …deliver device clinical outcomes that exceed quality benchmarks and regulatory standards. **Core Responsibilities:** **Device Clinical Strategy & Risk Management:** ... into technical requirements + Coordinate risk mitigation activities across clinical, regulatory , quality, and engineering functions + Perform safety reviews on… more
- Integra LifeSciences (Braintree, MA)
- …US Food and Drug Administration regulations, ISO 13485, and other applicable regulatory agencies as they pertain to laboratory testing. **ESSENTIAL DUTIES AND ... or other product development studies. + Assist in preparing for and participating in FDA audits, customer audits, etc. + All other duties as assigned DESIRED MINIMUM… more
- Nanobiosym, Inc. (Cambridge, MA)
- …responsible for the organization and the coordination of processes pertaining to regulatory compliance and quality systems to ensure regulatory requirements for ... including the creation and documentation of validation protocols that comply with FDA regulations. + Provide troubleshooting focus and direction for the team with… more
- Integra LifeSciences (Braintree, MA)
- …and manage time to meet organizational goals and objectives. + Experience with External Regulatory Agency audits (ie, Notified Bodies and FDA ). + Knowledge of ... The role works closely with Product Development, Project Management, Regulatory , Marketing and Medical Affairs. **ESSENTIAL DUTIES AND RESPONSIBILITIES** +… more