cGxPServe

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...

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...

Responsibilities: A minimum of eight 8 years of process/plant engineering experience in GMP MFG large molecule biologics facilities. Experience in green or brown field GMP MFG facility startup including process systems automation utilities facilities and operations. Strong technical 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: 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: 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...