- System One (Paulsboro, NJ)
- …to meet audit and compliance standards + Monitor and maintain compliance with FDA regulations, cGMP, ISO standards, and internal quality systems + Provide ... in validation protocol development, execution, and documentation + Familiarity with cGMP, FDA regulations, and ISO standards (including 21 CFR 11, 21 CFR Part… more
- Otsuka America Pharmaceutical Inc. (Trenton, NJ)
- …for consistent messaging. + Serves as the primary contact/liaison with the FDA Office of Prescription Drug Promotion (OPDP), responsible for establishing working ... procedures, as appropriate. + Recommends improvements to labeling policies, processes, quality , and system tools. Manages contracts for contractors and consultants.… more
- J&J Family of Companies (Raritan, NJ)
- …is responsible for providing operational support for the execution of Technology Quality compliance programs. This position is responsible for supporting audit and ... and Enterprise) GxP computerized systems that are supported by Technology Quality including a large global portfolio of computerized systems covering Manufacturing… more
- Terumo Medical Corporation (Somerset, NJ)
- … software + Some familiarity with SOX and IRM compliance + Some familiarity with FDA CFR Part 11 Software Validation processes + Keen analytical skills + Keen ... Corporation (TMC) develops, manufactures, and markets a complete, solutions-based portfolio of high- quality medical devices used in a broad range of applications for… more
- Bristol Myers Squibb (New Brunswick, NJ)
- …Development and Supply the team works closely with our partners to deliver quality products safely, effic iently and on time while operationalizing the innovative ... packaged clinical supplies while ensuring and maintaining compliance with all quality requirements. + Reviews the master production schedule and production orders,… more
- Fujifilm (Trenton, NJ)
- …levels. + Minimum five (5) years of progressive experience as a Technical, Systems, Software or Quality Assurance Engineer in Medical IT and/or Imaging products. ... review calls with assigned staff for the purposeof evaluating and reporting project quality and timeliness. + Manages assigned projects as required to meet company… more
- Terumo Medical Corporation (Somerset, NJ)
- … software Some familiarity with SOX and IRM compliance Some familiarity with FDA CFR Part 11 Software Validation processes Keen analytical skills Keen sense ... develops, manufactures, and markets a complete, solutions-based portfolio of high- quality medical devices used in a broad range of...drive clear economic value, better clinical outcomes and improved quality of life for patients. TMC is part of… more
- Cytel (Trenton, NJ)
- …environment. The ideal candidate will contribute to the maintenance of critical software libraries, support graphics development in R, and help generate Tables, ... standards for regulatory submissions is essential. + Develop and maintain open-source software platforms with a focus on usability, stability, and scalability. +… more
- Terumo Medical Corporation (Somerset, NJ)
- …Corporation (TMC) develops, manufactures, and markets a complete, solutions-based portfolio of high- quality medical devices used in a broad range of applications for ... programs that drive clear economic value, better clinical outcomes and improved quality of life for patients. TMC is part of Tokyo-based Terumo Corporation;… more
- Virtua Health (Voorhees, NJ)
- …by US News and World Report, we've received multiple awards for quality , safety, and outstanding work environment.In addition to five hospitals, seven emergency ... accreditation programs to ensure the standards for JCAHO, ACR, OSHA, NJDEP, FDA /MQSA, and NRC are maintained. Comprehensive and analytical reviews of QC/QA/QI data… more