cGxPServe

Job Description: We are seeking a motivated and innovative R&D Engineer to support the design development and testing of medical devices in compliance with FDA and ISO standards. The ideal candidate will work closely with cross-functional teams to bring new products from concept to co More...

Responsibilities: Perform core regional quality systems activities as assigned (e.g. revising procedures assisting in inspection readiness) following defined procedures. Develop improve and revise regional quality system SOPs. Conduct ongoing analysis and reporting of key quality and More...

Responsibilities: Maintain full awareness of all regulatory activities on assigned Project(s) and ensure that the project deadlines and performance standards for these projects are established and met. Also work with internal and external stakeholders to manage submission schedules. More...

Responsibilities: Supports necessary regulatory activities required for product market entry. Preparation of regulatory submissions for Electrophysiology Mapping and Imaging devices to achieve departmental and organizational objectives. Review and approve engineering change orders fo More...

Job Description: Positions are 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. Responsibili 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: Responsible for the oversight of all data management CRO activities supporting companys clinical programs from database start-up through database lock and CSR/submission. Serves as primary point of contact with the DM CROs 3rd party vendors and internal study teams. More...

Job Description: The Clinical Data Manager (CDM) is responsible for the oversight integrity and quality of clinical trial data from collection through database lock. The CDM ensures that data is accurate consistent and meets regulatory and protocol-specific requirements. This role col More...

Responsibilities: Preparing documentation for international regulatory registrations. Preparing technical documentation to compliant to MDD and EU MDR. Defining worldwide regulatory requirements are necessary for regulatory approval of products. Participating in cross functional team More...

Job Description: The Senior Supplier Quality Engineer will support External Manufacturing and Supplier Quality functions by executing both strategic and tactical quality activities. This includes base business support nonconformance (NC) root cause investigations and driving qua More...

Responsibilities: Review protocols for CDISC conformance. Review Case Report Forms and eCRFs with CDISC CDASH and SDTM conformant elements. Write and manage SAS code for mapping clinical data to SDTM data structures in conformance with Emmes SDTM Implementation Guide project standard More...

Job Description: Will be responsible to work in a team atmosphere on the production of medical equipment spare parts and accessories in accordance with quality specifications. Works within clearly defined SOPs and adheres to quality guidelines. High school diploma or equivalent. Zero More...

Job Description: Experienced Component Engineer with strong expertise in equipment and process validation including Installation Qualification (IQ) Operational Qualification (OQ) and Performance Qualification (PQ). Proven ability to manage component selection supplier coordination and More...

Responsibilities: Regulatory Labelling Documentation. Support the creation and maintenance of assigned labelling projects to enable worldwide regulatory submissions. Independently prepare and maintain the Tracking Sheets for the global regulatory dossiers related to labelling project More...

Responsibilities: The Sr. Statistical Programmer supports the Biostatistics team in the generation and validation of analysis datasets and statistical outputs for clinical trials. This role is key to implementing programming standards and supporting the standardization of CDISC-compl More...

Roles & Responsibilities: 7-10 years experience in Computer System Validation of SAAS systems and Cloud systems. Must have experience in Agile methodology and handled multiple releases in parallel. Has working experience in any one or two of the following domains Tool validation like More...

Job description: The Laboratory Coordinator will develop and administer various laboratory equipment support functions throughout AbbVie R&D sites. This position involves serving as liaison among internal AbbVie personnel as well as external organizations to aid in equipment selection More...

Job Description: We are looking for a Validation Specialist IV who will lead validation and compliance activities for computerized systems analytical instruments and enterprise software. This includes supporting system implementation upgrades administration and retirement while ensuri More...

Job Description: Ensures through global and local Product Development Process procedures and efforts that product software are developed tested and transferred according to established procedures that will assure that they meet all quality requirements. Responsible to assist in the m More...

Job Description: Reporting directly to the division Sterilization Quality Engineer Lead this position involves support for the sterilization operations and product sterility assurance program. This position provides quality guidance for product and process sterility product resolutio More...