- J&J Family of Companies (Gurabo, PR)
- …United States of America **Job Description:** Responsable de revisar la documentacion de los " Batch Records " electronicos y de papel del area de Manufactura y de ... libros de registro ("logbooks") y del manejo de documentos (" Records & Information Management") del area de Manufactura. Debe...industria relacionada o un ano en el area de Batch Record . + Buen conocimiento de la… more
- CVS Health (Scottsdale, AZ)
- …of team lead. **Required Qualifications:** + 3-5 years experience in a Data Center Batch Operations role and knowledge of ROBOT and IWS scheduling tools. ... it all with heart, each and every day. **Position Summary** Provides operational support for batch processing, systems hardware, peripherals and software within… more
- Lilly (Richmond, VA)
- …controls and deviations. + Originate and investigate deviations associated with batch records . + Work with Lilly support groups to resolve product related ... Review and approve complaint investigations. + Consult on Master batch record updates; provide input based on...schedule flexibility and off hours may be necessary to support operations . + Some travel (<10%) is… more
- Astellas Pharma (Westborough, MA)
- …+ Compliance Execution: Oversee timely and accurate QA review of GMP documentation, including batch records and QC data. Support batch disposition ... QA operations , provide strategic input into quality initiatives, and support the qualification and ongoing GMP readiness of AIRM's clinical manufacturing… more
- Catalent Pharma Solutions (Harmans, MD)
- …with appropriate internal departments. + Coordinate the preparation/revision of master batch records , SOPs, and review/close-out all cGMP documents, including ... Control, MS&T and other internal and external functions to support successful batch production. + Assure accurate...cGMP suites. + Provide direct supervision, training, and hands-on support of production staff in the operation … more
- Sanofi Group (Framingham, MA)
- …Alarms and NRSR * Initiate and investigate and QA review deviations * Provide off-hour support for batch record and log book issuance Represent for QA ... as shift lead including developing junior employees * Perform batch record review * Perform review of...to the required standards * Partner with manufacturing and support operations to ensure a culture of… more
- Lilly (Durham, NC)
- …fields. + 3+ years' experience with design, development, testing, delivery, and support of Electronic Batch Record (s) using Rockwell PharmaSuite ... technical oversight and input into the development and deployment of MES Electronic Batch Record (EBR) and ancillary electronic tickets to new manufacturing… more
- Lilly (Durham, NC)
- …systems related fields. + 5+ years' experience with design, development, testing, delivery, support of Electronic Batch Record (s) using Rockwell PharmaSuite ... pharmaceuticals. **Additional Skills/Preferences** + Experience with design, development, testing, delivery, support of Electronic Batch Record (s) using… more
- Catalent Pharma Solutions (Harmans, MD)
- **Job Title:** Supervisor, Manufacturing Batch Record Review **Location:** Harmans, Maryland **Company:** Catalent Inc. **About Us:** Catalent, Inc. is a leading ... viral vector-based therapies and vaccines. **Position Overview:** The Supervisor, Manufacturing Batch Record Review is responsible for providing oversight and… more
- Fujifilm (Thousand Oaks, CA)
- …batch management systems, including recipe development to manufacture cell therapy products. + Support in batch record and document creation with new ... of manufacturing execution systems (MES Recipes). + Technical SME on manufacturing processes. + Support the day-to-day operations of the electronic … more