cGxPServe

Responsibilities: CSV Analytical and Enterprise Validation specialist IV will lead validation activities including but not limited to software updates new system introduction Administration of systems and applications and decommissioning activities as appropriate. This person will wo المزيد...

Responsibilities: In this critical role you will lead regulatory strategies product submissions and a team of talented regulatory affairs professionals to drive timely product approvals and ensure ongoing regulatory compliance in key markets such as USA (FDA) EU (MDR) China (NMPA) an المزيد...

Job Description: The Finishing Support Associate helps with assembling kits preparing packaging materials and supporting finishing area activities. This role follows safety and quality procedures in a clean manufacturing environment. Responsibilities: Assemble kits and screen product المزيد...

Responsibilities: Contribute with your statistical expertise to the design and analysis of one or more clinical trials or the clinical development plan of one compound/program. Will closely collaborate with program partners and stakeholders to deliver on the statistical deliverables المزيد...

Responsibilities: Upstream/downstream process and CQV support (ex. autoclaves parts washers incubators Isolators HVAC). Managing and working collaboratively with clients quality representative to complete deviation investigation and resolution for problems and issues encountered duri المزيد...

Job Description: The Senior Quality Engineer is responsible for the quality safety and reliability of the clients products. This role requires expertise in supplier design manufacturing and software quality engineering. The engineer must demonstrate an understanding of consumables an المزيد...

Responsibilities: CSV Analytical and Enterprise Validation specialist IV will lead validation activities including but not limited to software updates new system introduction Administration of systems and applications and decommissioning activities as appropriate. This person will wo المزيد...

Responsibilities: Lead and manage computer system validation (CSV) projects including authoring and executing specifications and validation documentation for enterprise systems. Develop and author validation protocols ensuring compliance with 21 CFR Part 11 Annex 11 GxP and internal المزيد...

Responsibilities: Lead programming efforts for various clinical studies from Phase 1 to Phase 3 across multiple therapeutic areas. Develop and review annotated Case Report Forms (CRFs) and SDTM datasets ensuring accurate data representation. Program SDTM ADaM and TLFs and write detai المزيد...

Job Description: The Data Manager Data Management Oncology Early Development (OED) is a member of the Data Management and Analysis team responsible for supporting the successful delivery of data and processes conducted by CROs. This individual will collaborate closely with the Data Ma المزيد...

Job Description: The Manufacturing Engineer 3 Senior Manufacturing Engineer provides a key technical interface to a critical contract manufacturing relationship. The contract manufacturer provides a system consisting of electromechanical capital equipment as well as high-volume steril المزيد...

Responsibilities: Investigate and resolve supplier-related quality issues and non-conformances. Conduct risk assessments and support root cause analysis for incoming quality control issues. Monitor supplier performance and support supplier quality improvement initiatives. Collaborate المزيد...

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 المزيد...

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 المزيد...

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. المزيد...

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 المزيد...

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 المزيد...

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 المزيد...

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. المزيد...

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 المزيد...