- Amgen (Holly Springs, NC)
- …most advanced drug substance manufacturing plant. When completed, the Amgen FleX Batch facility will combine the latest in disposable technologies with traditional ... to allow for maximum flexibility in operations. The FleX Batch facility will not only feature the best in-class...carbon-neutral company by 2027. **Senior Associate Manufacturing - Electronic Batch Record Support** **What you will do** Let's do… more
- ThermoFisher Scientific (Greenville, NC)
- …development to commercialization. **POSITION SUMMARY** The Quality Assurance (QA) Supervisor, Batch Release oversees QA activities and programs such as auditing, ... is an advantage. + Familiarity with concepts, practices, and procedures related to Batch Release activities. + Ability to manage and lead professional staff to… more
- Glenmark Pharmaceuticals Inc., USA (Monroe, NC)
- …head-on. POSITION SUMMARY: The Operations BPR Lead is responsible for the real time batch record review program in manufacturing as a proactive measure of batch ... in advance to improve schedule adherence. In addition, the batch record cycle is not complete until the record...with proper corrections completed. This position will be a batch record and process SME to expedite the … more
- Gilead Sciences, Inc. (Raleigh, NC)
- …therapeutics for people with life-threatening diseases. We are seeking an experienced SAP Batch Release Hub (BRH) Architect with a strong background in Life Sciences ... to lead the design and implementation of SAP Batch Release Hub solutions. The ideal candidate will possess...GxP and FDA), and life sciences Quality Management and Batch Release processes. As an SAP BRH Architect, you… more
- Ensono (Raleigh, NC)
- …Summary** The Scheduling Analyst provides technical support maintaining new and existing batch schedules using certain batch scheduling tools. They perform ... mainframe and/or a client server environment, to maintain the batch schedules as well as assist with ongoing technical...technical schedule support to both the application teams and batch operation team. Position reports to Team Lead, Scheduling,… more
- Grifols Shared Services North America, Inc (Clayton, NC)
- …in quality systems such as Change Control, Discrepancy Management, Quarantine, Batch Release, SAP, SAP Quality Module, Documentation, and Annual Product Reviews ... release certificates of analysis, preparation of periodic RA reports, tracking batch release status including accepted, rejected, reprocessed, and reworked batches.… more
- Fujifilm (Holly Springs, NC)
- …**Job Description** **What You'll Do** * Performs and manages batch release activities for production including, but not limited to, ... review of batch records, analytical data, certificates of analysis, and other...other documents. Acts as Release Responsible Person for DSM Batch Disposition as applicable * Participates in establishing programs… more
- Lilly (Concord, NC)
- …and/or finished drug products and provide guidance to sites on batch -related issues, including non-conformance investigations, issue resolution, and other batch ... to help define the future-state vision for manufacturing. + Support batch disposition for semi-finished and/or finished drug product batches) to ensure… more
- Mallinckrodt Pharmaceuticals (Raleigh, NC)
- …manufacturing responsibilities. This includes understanding and following all applicable batch records, standard operating procedures and work instructions, and ... indicators, and HMI displays (for PLC and DCS controls) following applicable batch records, procedures, and good documentation practices. + Operates and monitors… more
- Actalent (Clayton, NC)
- …demand. The primary responsibilities include loading materials, completing electronic batch records, logging book entries, documenting work orders, performing ... process checks for quality assurance, and managing batch packaging records. A tech-savvy attitude and a focus...Load materials and manage production processes. + Complete electronic batch records and log book entries. + Document work… more