cGxPServe

Responsibilities: Designs and engineers the solution down to detail to satisfy the specified requirements of the customer. Defines the products components and systems to be used and their concrete characteristics. Configures the components and systems of the solution according to th More...

Roles & Responsibilities: Full lifecycle validation for all applicable computerized systems ensuring they are designed validated operated and retired in compliance with GxP regulation and computer system validation (CSV) guidance. Compiling and maintaining accurate CSV documentation More...

Job description: We are seeking a managerlevel contractor role to support Neuroscience portfolio assets. The contractor will have the opportunity to support launch and onmarket assets in Migraine. The purpose of this role is to provide meaningful handson research experience and profes More...

Job description: We are seeking a managerlevel contractor role to support Neuroscience portfolio assets. The contractor will have the opportunity to support launch and onmarket assets in Migraine. The purpose of this role is to provide meaningful handson research experience and profes More...

Roles & Responsibilities: Advanced Degree in Engineering or related discipline. Develops and improves manufacturing processes by studying product and manufacturing methods. Evaluates manufacturing processes by designing and conducting research programs; applying knowledge of product More...

Job Description: Biologics Developability Screening and Automation The Biologics CMC Developability team is an integral part of the Biologics CMC Drug Product Development organization at AbbVie. The Biologics CMC Developability team is responsible for 1 the identification of biophysi More...

Responsibilities: Provides input into the design of data flow across EDC and nonEDC data sources across vendor network Manages data management service providers to ensure the quality of deliverables and that timelines are met Develops and contributes to the design of processes enabli More...

Roles & Responsibilities: Generate validation documents & facilitate approvals. Provide fat and sat support. Require manager references. Execute qualification protocols (IOQ & PQ) in a cleanroom environment. Generate postexecution documentation (executed protocols summary reports).

Responsibilities: Join a leading biopharma company supporting critical regulatory systems initiatives. Were seeking a detailoriented consultant with expertise in Regulatory Systems eCTD submission management and experience working with global IT and crossfunctional teams to drive sys More...

Job description: We are seeking a managerlevel contractor role to support Neuroscience portfolio assets. The contractor will have the opportunity to support launch and onmarket assets in Migraine. The purpose of this role is to provide meaningful handson research experience and profes More...

Responsibilities: Lead and execute Design Verification and Validation (V&V) activities for disposable kit development. Define test plans methodology test equipment and resources to support design Verification and Validation activities. Setup design of experiments (DOE) and/or rev More...

Job Description Positions available for both handling and collecting blood from horseshoe crabs and processing the blood in a laboratory setting. Selected workers will be trained in all SOPs and cGMPs as well as general aseptic processing and disinfecting techniques Responsibilities More...

Responsibilities: We are seeking a highly motivated and organized individual to fill the role of Associate Clinical Data Manager. As a key member of our team you will be responsible for managing clinical data and ensuring its quality and integrity. Oversee the collection and manageme 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...

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: 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...