Responsibilities: Process and equipment qualification (IQ/OQ/PQ). Development of test methods for Design V&V, Process Validation, and Production. Validation of test methods. Execution of Engineering Builds, Gauge R&R Studies, Attribute...
Responsibilities: Devises sampling procedures and designs and develops forms and instructions for recording, evaluating, and reporting quality and reliability data. Establishes program to evaluate precision and accuracy of production equ...
Responsibilities: Lead technical teams to ensure successful device development. Work cross-functionally with Marketing, Operations, and Development teams. Develop detailed engineering specifications and design documents. Support verifi...
Responsibilities: Execute and troubleshoot high-throughput analytical methods, including capillary electrophoresis, chromatography (HPLC/UPLC), and spectroscopy, to support biologic molecule development. Collaborate with cross-functional...
Responsibilities: Candidate mssess a bachelor's degree in engineering, or a scientific or quality assurance discipline. Awareness of Design controls and change controls for FDA regulated medical devices (21 CFR 820.20 and ISO13285 standa...
. Requirements: NJ RN license from an accredited school of nursing. Associates degree required, BSN or BS in Life Science preferred...
Responsibilities: Independently perform routine drug metabolism assays and generate high quality data, noting significant deviations to be elevated to senior staff. Collaborate with department team members including Bioanalytical counter...
Responsibilities: Lead development and implementation of the GCP supplier audit and compliance strategy for clinical development programs, GMA and MPG studies. Serve as primary point person for key GCP strategic partners;lead key suppli...
Responsibilities: Establish strong scientific and technical initiatives and hands-on implementation for new in vitro models. Execution of in vitro experiments to create cellular models in immortalized cell lines, primary neurons and/or i...
Responsibilities: Lead development and implementation of the GCP supplier audit and compliance strategy for clinical development programs, GMA and MPG studies. Serve as primary point person for key GCP strategic partners;lead key suppli...