- Cipla (Hauppauge, NY)
- …responsible for review of batch production records, ensuring that all documentation complies with Good Manufacturing Practices (GMP), regulatory standards, and ... internal quality assurance procedures. This role ensures the integrity , accuracy, and completeness of batch records related to pharmaceutical manufacturing… more
- Fresenius Medical Care (Olmito, TX)
- …, including new hire orientation, compliance training , and mandatory in-service training . Ensure all required and appropriate documentation is completed, ... . Oversees the continuous and data driven Quality Assurance and Performance Improvement Program of the center, including collection and analyzing of data per policy… more
- Merck & Co. (Rahway, NJ)
- …is capable of meeting all historic, currently existing, and cutting-edge biologics program demands from supporting development to pilot scale, small and large scale ... needs.Execute and develop appropriate system validation, change control, and testing documentation in partnership with project CQV and IT teams.Support establishment… more
- Insmed Incorporated (NJ)
- …compliance with company policies and regulatory standards, and the quality and integrity of all reviewed materials. By driving process excellence, governance, and ... completeness, and readiness for MRC review; verify metadata, supporting documentation , and references.Ensure accurate documentation of reviewer comments,… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …engagement and revenue opportunities while maintaining regulatory and operational integrity . Relationships The position reports to the Director, Field Alignment ... with evolving strategy and regulatory requirements Govern the file library and documentation : manage all files generated during the call-plan process, and ensure… more
- Genmab (NJ)
- …practices, as well as global agency regulations/guidance's Creates any needed documentation and training for standard processes, change control management ... Manager, Clinical Programming is responsible for the establishment, governance, and integrity of Study Data Tabulation Model (SDTM) standards, perform sponsor… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …collaboration across relevant cross functional groups to establish a strong, compliant program to enable robust production, testing and release of product to ... maintains network configuration for BAS, EMS, and facility automation equipment.Provides training to end usersProvides user defined reports and facilitates ad-hoc… more
- Formation Bio (New York, NY)
- …strategic development and operational management of Formation Bio's quality assurance program to support the growing drug development capabilities. This position ... through internal and external partnership. Responsibilities Oversee GXP, Data Integrity , and CSV activities across various entities, investigator sites, research… more
- Cipla (Hauppauge, NY)
- …outgoing goods, ensuring adherence to Good Distribution Practices (GDP) and product integrity . Affixing approved labels on the approved materials, once release from ... to perform other relevant transactions in SAP. Ensure completion of individual training assigned and follow company policies, safety requirements, cGMP and SOP's. To… more
- Loma Linda University Faculty Medical Group (Loma Linda, CA)
- …cases each year, including heart transplants. There is an established pediatric fellowship training program and a robust residency program . Loma Linda ... already robust research enterprise through a new collaborative research center and program endowment. Loma Linda University Health continues to lead in integrating a… more
