- Legend Biotech USA, Inc. (Raritan, NJ)
- …of records for regulatory inspections and internal audits.Ability to utilize multiple electronic quality systems and SAP.Knowledge of cGMP regulations and FDA/EU ... assigned by management and continue to develop professionally.Strong proficiency utilizing electronic Quality Systems per curriculum.Utilizes tools within MS… more
- Merck & Co. (Durham, NC)
- …facility will be used to produce the bulk active ingredient, finished product , and laboratory testing for the BCG vaccine.The Quality Operations Laboratory Manager ... start-up testing in new laboratories using principles of our Production Systems , Lean Laboratories, and GMP requirements.- GENERAL PROFILE: Work cross-functionally… more
- Merck & Co. (Durham, NC)
- … Systems , Water for Injection (WFI), and Clean Steam (CS)) Automated Systems (eg Distributed Control System (DCS), Programmable Logic Controllers (PLC), ... operation, maintenance and/or troubleshooting experience with complex process and/or utility systems Experience using electronic manufacturing systems (eg… more
- Merck & Co. (Durham, NC)
- …for the quality aspects of good manufacturing practices (GMP) computerized systems and the supporting infrastructure used in site facilities, utilities, ... regulatory expectations. Be involved in all quality-related activities for computerized systems which are required by the company manufacturing division Quality… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …support Regulatory Inspections for QC.Perform peer review/approval of laboratory data.Utilize electronic systems (LIMS) for execution and documentation of ... with responsibilities for supervising the operation and workflow of the quality control laboratories in support of cell therapy manufacturing. This includes hiring,… more
- Merck & Co. (Durham, NC)
- Job DescriptionSenior Specialist, Quality Systems and Compliance (P3) Our company is expanding its global recombinant vaccine production network by investing and ... and CAPA experience, Batch Record Review, Validation IQ, OQ, PQ, Change Control . Has in-depth knowledge of cGMPs and domestic and international regulatory… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …will be part of Manufacturing Excellence team reporting to the Manufacturing Execution Systems Lead and will be responsible for EBR development and administration at ... QA, Reg CMC, and IT. This individual will support electronic batch record (EBR) updates and system improvements, support...responsible for gaining the necessary process knowledge of the product to develop EBR designs that fit the site's… more
- Cummins Inc. (Columbus, IN)
- …States. In this early career product focused role, you will tailor electronic and electrical systems for Cummins products. You will translate product ... **DESCRIPTION** We are looking for a talented Product Performance and Controls Integration Engineer...integrated hardware and software systems . + Investigate electronic application, system and product issues, understands… more
- Cummins Inc. (Columbus, IN)
- …a talented Product Control Engineers to join our team specializing in Electronic Systems for our Corporate Business at one of our Cummins Inc. locations, ... products in a variety of customer applications. As a Product Controls Engineer, you will: + Be... electronic hardware and interconnections to measure and control systems . + Working to meet customer… more
- Cummins Inc. (Columbus, IN)
- …for a talented Product Software Engineer to join our team specializing in Electronic Systems for our Corporate Business at one of our Cummins Inc. locations, ... controls the operation of Cummins' products, + Investigate product software problems, understand causal mechanisms, recommends appropriate action, own problem… more
