- Rhythm Pharmaceuticals (Boston, MA)
- …office to play a key role in ensuring quality and regulation-based compliance during the manufacture and distribution of Rhythm clinical and commercial products. ... administration of quality processes and records, ensuring operational excellence in GxP compliance , and maintaining a state of inspection readiness. The Manager, QA,… more
- Hologic (Marlborough, MA)
- …Management System. In this role, you'll be responsible for ensuring compliance with global regulations, championing advanced quality tools, and driving continuous ... quality, we want to hear from you! **Knowledge:** + In-depth understanding of FDA Quality System Regulations, ISO 13485, and Medical Device Directive. + Expertise in… more
- NTT DATA North America (Canton, MA)
- …ABAP and BTP). Ensure adherence to SAP best practices, governance frameworks, and compliance standards. Ensure alignment with GxP, FDA , EMA, and other regulatory ... or medical device environments and can deliver SAP solutions that drive compliance , innovation, and business value **Key Responsibilities** + Lead and manage… more
- Cambrex High Point (Waltham, MA)
- …and other compendial tests as required to support product release, stability, and compliance . + Author and review analytical protocols, reports, and SOPs in ... compliance with GMP and regulatory expectations. + Conduct GMP...knowledge of GMP requirements, ICH guidelines, and regulatory expectations ( FDA , EMA). + Experience in quality control testing, stability… more
- ThermoFisher Scientific (Agawam, MA)
- …the Life** + Responsible for overall distribution center cost, service, compliance , and safety through productivity and performance metrics including all receiving, ... team's focus on safety and obtains and maintains 100% compliance in all required training. + Monitors, reports and...of materials is in keeping with State and Federal FDA , Board of Pharmacy, DEA, ATF, EPA and OSHA… more
- Dana-Farber Cancer Institute (Brookline, MA)
- The Clinical Trials Monitor helps to ensure compliance of the clinical research enterprise with all related regulatory policies and guidelines, including federal, ... and related activities occur as outlined in the monitoring plan and in compliance with all related regulatory standards. Monitoring will be performed through a… more
- Regeneron Pharmaceuticals (Cambridge, MA)
- …a highly skilled, self-motivated **Senior Validation Specialist- CSV** to ensure compliance of computerized systems with regulatory requirements in the life sciences ... will be responsible for planning, executing, and documenting validation activities to meet FDA and potentially other global regulatory standards such as 21 CFR Part… more
- Hologic (Marlborough, MA)
- …MA, United States Are you passionate about ensuring top-notch quality and compliance in manufacturing? We're looking for a detail-oriented and proactive **Supplier ... dynamic team! In this role, you'll execute activities to ensure compliance with regulatory standards and Quality Management System requirements, conduct technical… more
- BioLife Plasma Services (Boston, MA)
- …management. Gain exposure to real-world challenges such as audit processes, compliance requirements, and team performance management. + **Production Environment & ... service by assisting with production tasks while maintaining strict regulatory compliance and safety standards. + **Develop Leadership and Employee Relations… more
- Charles River Laboratories (Boston, MA)
- …that the health and welfare of laboratory animals are maintained in compliance with local, state, federal and institutional guidelines and regulations. Responsible ... and implementation of site-specific standard operating procedures (SOP's), in compliance with all state, federal and industry requirements. Oversee adherence… more