cGxPServe

Job Description: Engages cross functionally to investigate and document compliance events ensuring timely resolution to enable program timelines. Works with Databases and electronic systems. Follows through with business partners to receive investigation results actions planned and cl More...

Roles & Responsibilities: Under general supervision responsible for the coordination and the preparation of documents/packages for regulatory submissions. Review and evaluate technical and scientific data and reports required for submission in support of companies products. This sect More...

Responsibilities: The Data Manager will lead data management (DM) activities for clinical trials including database setup study conduct and closeout. The Data Manager will work collaboratively with a crossfunctional team to maintain project timelines and to deliver highquality DM del More...

Job Summary: This position will support the Sterility Assurance R&D organization by coordinating activities related to separation and R&D footprint activities. Including but not limited to setting up project management tools leading meetings and tracking work activities as described i More...

Responsibilities: Manufacturing Support: Develop technical knowledge on manufacturing equipment and processes. Support resolution of major equipment breakdowns and quality issues in the suites. Provide SME support to Manufacturing and other departments for them. design and operati More...

Responsibilities: Planning and of plant projects involving complex equipment changes. Work with Quality group to draft change requests and gain stakeholder alignment. Own change requests and complete change request tasks to support project completion. Daily onsite management for mul More...

Responsibilities: Execute the historical performance review (HPR) a periodic review of equipment performance and use. Compile data gathered from HPR and use to analyze trends that could show equipment failure or out of trend. Review equipment logbooks procedures and use for adherenc More...

Responsibilities: Investigate maintain and manage regulatory product certification claims data databases and documentation systems. Ensure accurate data entries and effective database management. Review technical documents to retrieve information with a high level of accuracy. Maint More...

Roles & Responsibilities: This is an entry level position in a clean environment that requires gown training. Contributes within the team using SAP DMS Trackwise and Syncade systems for receipt storage issuance and allocating components. Demonstrates organization communications and t More...

Job Description: We are seeking a Quality Control Technical Transfer Analyst 3 to join our Quality Control team. This role supports production by contributing to technical transfer activities and ensuring highquality testing for inprocess materials final products and stability studies More...

Responsibilities: This is a key functional role within the Design and Reliability Assurance Engineering team. The role involves the process of planning organizing leading and reporting all risk management activities through collaboration with cross functional teams. This role is res More...

Responsibilities: Create and validate CDISC compliant SDTM domains and ADaM datasets using advanced SAS software tools. Develop specifications to map CRF and another form of raw data to appropriate SDTM domains. Create specifications to map SDTM data to ADaM and be able to write cle More...

Responsibilities: Lead project after deal closure. Direct lead and motivate multidisciplinary project teams and hold team members accountable to deliver results within an agreed project governance structure to ensure customer satisfaction throughout the life of the program. Shared c More...

Responsibilities: The Senior Statistical Programmer I will assist the US and/or EU Early Phase Statistical Programming teams by developing SAS programs for analysis datasets. They will be responsible for listing and safety summary tables providing project tracking information to the More...

Responsibilities: Individual will be responsible for small and large team meeting planning scheduling facilitation and organization (virtual and inperson events often for large and/or senior audiences) stakeholder management collaboration with Business Services Group (BSG) for event More...

Job Description: In this Position of IT Quality Assurance Associate you will support implementation and operational aspects of IT systems while ensuring compliance with internal and external requirements. Responsibilities: Provide compliance guidance across IT and stakeholders f More...

Job Description: The Medical Editor Value & Access is responsible for reviewing editing and supporting documents developed by Value & Access including AMCP dossiers compendia and product monographs. This individual provides editorial expertise for multiple projects across therapeutic More...

Job Description: The Medical Device Safety team is a highly diverse department that plays a critical role in conceptualizing designing and implementing highpriority analytical strategies clinical oversight and initiatives. The team is a highprofile highimpact team that works with PSQ More...

Responsibilities: Conceives plans and executes manufacturing process validations plans and studies. Adhere to the Change Control and Design Control requirements. To create robust validation documents such as Master Validation Plans / Report IQ OQ & PQs. Being the lead on the writing More...

Responsibilities: Research and test the design functionality and maintenance of products equipment systems and processes and develop quality standards. Ability to read and interpret blueprints and evaluate product integrity and standards. Typically has a bachelors degree in an engine More...