cGxPServe

Responsibilities: The Quality Engineer is responsible for maintaining quality and control of manufacturing processes and postmarket performance of medical devices. Responsibilities include collaborating with internal and external stakeholders to achieve company objectives leading tec More...

Responsibilities: Lead validation planning risk assessment and for R Studio GitLab and Medidata Rave EDC. Develop and execute validation documentation including: Validation Plans (VP.. User Requirements Specifications (URS.. Risk Assessments (RA.. Functional and Design Specification More...

Responsibilities: Lead data management activities ensuring accuracy consistency and compliance with regulatory standards. Oversee database build activities data collection coding cleaning and database lock. Develop and execute data management plans including risk management strategie More...

Responsibilities: This position IS NOT related to shipping OR shipment packaging. This is a manufacturing type position and involves filling of liquid antibodies into small vials in a laboratory environment and using lab instruments such as pipettes peristaltic pumps and analytical More...

Responsibilities: Plan and execute Validation & Verification (V&V) protocols for medical devices. Collaborate with Test Method Validation (TMV) team to address skill gaps. Lead V&V efforts within R&D focusing on documentation and planning. Ensure sample size justification and all V& More...

Responsibilities: The Senior Clinical Data Manager will oversee various procedures templates and meetings within the Data Management (DM) team. They will lead the coordination of data management activities across multiple projects ensuring seamless integration and efficient . This r More...

Responsibilities: Provide SAS programming support for clinical trials supporting registrations and creating of reports for publications and other ad hoc analyses. Develop SAS programs to generate TLFs to meet requirements using Base SAS SAS Macros SAS/STAT SAS/Graph SAS/SQL within a More...

Job Description: This role requires face to face interactions with our subjects. It also requires hands on skills that require physical contact with some activities. (ex: phlebotomy ECG collections vitals signs). Responsibilities: Review protocols and comply with studyspecific acti More...

Roles & Responsibilities: Quality assurance/Quality engineering/Quality Inspection/Root cause analysis. Supplier quality ISO 9001 Kaizen 6 Sigma Quality control. Proven experience in Quality Assurance within automotive transit/rail or aerospace and defense industries. Prior experienc More...

Job Description: Impeccable lab practices including aseptic cell line/primary cell maintenance and stimulation. Selfmotivated with excellent attention to detail. Demonstrated ability to optimize cell culture conditions phenotypical assays Western Blot migration/contraction assays (fi More...

Job Description: The successful candidate will lead investigation of innovative devicebased drug delivery solutions to improve tissue exposure when systemic delivery does not fully exploit the potential of our . In close collaboration with partner functions in Discovery and Developme More...

Responsibilities: We are seeking a dedicated Regulatory Affairs Specialist to manage and coordinate our regulatory submission processes. This role offers the flexibility of being fully remote or hybrid catering to your worklife balance needs. Coordinate and prepare documents/packag More...

Responsibilities: The Senior Clinical Data Manager will oversee various procedures templates and meetings within the Data Management (DM) team. They will lead the coordination of data management activities across multiple projects ensuring seamless integration and efficient . This ro More...

Responsibilities: The Compliance Engineer will be integral to Caterpillars New Product and New Technology programs supporting engineering teams developing Drivetrain Components Batteries Chargers and Fuel Cells to ensure compliance with product regulations and safety standards. The r More...

Responsibilities: Develop and perform SAS programming for data processing and analysis. Collaborate with statisticians and other programmers to ensure accuracy consistency and adherence to quality control (QC) procedures. Support study deliverables and manage timelines for statistic More...

Job Description The Senior Statistical Analyst is a key role in the research and development of new pharmaceutical products. The primary responsibilities for this role include the analysis and reporting of clinical trial data and leading the statistical programming activities for clin More...

Job Summary: Product Development Science and Technology (PDS&T) is seeking a motivated Scientist to support parenteral drug product process development scaleup and technology transfer to commercial manufacturing sites. This role will focus on the development of robust manufacturing pr More...

Job Description: Are you a skilled Senior Project Manager with deep experience in delivering complex crossfunctional projects in regulated industries Were looking for a proven leader to guide the implementation of the Apriso MES system enabling digital transformation at a steriliza More...

Responsibilities: Coordinates design review meetings to review all quality aspects of new products. Interfaces with Product Development Engineers to ensure quality considerations during the concept stage. Support Design Control activities by ensuring compliance with FDA and internati More...

Job Description: The Senior Manager/Associate Director Medical Communications Ad Promo represents the Medical function in the Material Review Process to guarantee medical clinical and scientific data accuracy relevance objectivity balance and alignment with product label. Functions as More...