cGxPServe

Responsibilities: Reporting to the Clinical Data Manager youll be responsible for the development of real-world data variables from structured and unstructured data sources including designing data capture forms and supplemental procedures to instruct the abstraction process. Youll l More...

Job Description: We are seeking a Design Assurance Engineer with a strong mechanical background and hands-on experience in the medical device manufacturing industry. This role will play a key part in supporting product development ensuring design documentation accuracy and driving com More...

Responsibilities: Lead and manage clinical data management activities for oncology clinical trials ensuring adherence to project timelines budgets and quality standards. Provide strategic oversight and direction to CRO clinical data management teams for assigned studies. Develop and More...

Job Description: The Senior Engineer External Manufacturing and Supplier Quality provides strategic and tactical support to External Manufacturing by executing quality activities such as base business support and nonconformance root cause investigation to maintain and improve customer More...

Responsibilities: This role is responsible for Regulatory Affairs support of submissions and ongoing regulatory compliance for product development process and sustaining engineering projects ensuring compliance with FDA and EU regulations ISO standards and other regulatory agencies. More...

Job Description: This position supports quality activities within Commercial Quality including compliance with controlled substance regulations complaint handling change control documentation and audit coordination. The role requires adherence to environmental policies and contributio More...

Responsibilities: The scientist will conduct analytical experiments to support structural characterization and identification of biological macromolecules using liquid chromatography and mass spectrometry. The selected candidate will be responsible for maintaining the Protein Open-Ac More...

Roles & Responsibilities: Good at ISO standards (ISO 14001 ISO 9001 ISO 45001). Experience in interacting with Customer to understand the quality issues and solve them. Shop floor experience on quality issues and providing solutions. Experience in Calibrations. Experience in Six Sigm More...

Responsibilities: Provide leadership strategic planning direction and implementation of clinical systems for data collection which may include vendor selection budgeting resource planning vendor oversight EDC build and study timelines etc. Perform or provide oversight to staff for al More...

Responsibilities: Responsible for providing guidance to ensure that all regulatory submissions are planned communicated and performed per regulatory and business addition this position serves as a subject matter expert on various regulations coordinating regulatory issue resolution More...

Responsibilities: Follow all company safety rules regulations and job safety analysis. Must complete plant lock out procedures and key interrupt. Fill and operate shelf carton erector and clear minor jams. Responsible for quality of product including but not limited to. Discarding ob More...

Job description: As a member of the Clients Acute Therapies Verification and Validation engineering team you would be responsible for supporting product verification validation and compliance test activities on electrical and mechanical medical device components/systems. Your expertis More...

Responsibilities: Effectively designs and codes SAS programs using BASE/SAS SAS/STAT SAS/GRAPH and SAS MACROS for assigned clinical projects(s). Produces and delivers CDISC and regulatory compliant SDTM and ADaM standard datasets. Creates and validates tables figures and listings (TF More...

Responsibilities: To support the Biostatistics team by carrying out programming activities of statistical programmers and overseeing external vendors (as required) and to ensure timely and accurate programming and validation activities for clinical studies and publications. Contribut More...

Responsibilities: Provides leadership/expertise in day-to-day statistical programming in support of ongoing projects. Develops and/or validates SAS programs to generate SDTM/ADaM datasets following industry standards regulatory requirements and statistical instructions. Develops and/ More...

Responsibilities: Create and support review of validation life cycle documents for Analytical Instrument Qualification and computerized systems. Experience in validation of analytical instrument systems (e.g. benchtop analytical systems - spectroscopy chromatography protein analyzers More...

Job Description: The Biotherapeutics and Genetic Medicine Group is seeking a highly motivated scientist for initiating the lentiviral delivery platform for gene therapy in a newly established Genetic Medicine team. The candidate will work collaboratively with cross-functional and ther More...

Job Description: We are seeking a Logistics Sampling Associate to support night shift operations within our Logistics department. The associate is responsible for sampling and handling incoming raw materials maintaining cleanroom standards and ensuring compliance with cGMP and SOPs. T More...

Roles & Responsibilities: Leads cross functional teams through the planning execution and completion of a large scale program or several small projects with complex features. Leads projects within clients product lifecycle management (PDLM) and change control management (CCM) process More...

Responsibilities: Participate in developing and maintaining clinical trial data and statistical programming standards to ensure the company standards are up to date and in line with pharmaceutical industry standards conventions and regulatory requirements. Perform hands on primary st More...