cGxPServe

Responsibilities: Convert specifications into SAS code to generate datasets and Tables Listings and Figures outputs. Be responsible for overall project delivery including clinical trial reports and other regulatory submission deliverables. Create statistical analysis outputs to be us More...

Job Description: Perform operations maintaining product quality and production levels. Work as a team member for maximum effectiveness. Responsibilities include product inspection operating equipment raw material/finished goods movement and cleaning /sanitizing. Monitor machine functi More...

Job Description: Perform operations maintaining product quality and production levels. Work as a team member for maximum effectiveness. Responsibilities include product inspection operating equipment raw material/finished goods movement and cleaning /sanitizing. Monitor machine functi More...

Job Description: The Quality Engineering Manager will lead all Quality Engineering activities and incoming quality issues. Ensure all quality related systems of the plant are established and documented to provide a safe and effective product. Build sound technical and organizational c More...

Job Description: The scope includes thermal mapping and qualification of various GMP equipment with a strong focus on controlled temperature units and laboratory devices. Responsibilities: Preparation and execution of Qualification Protocols and Reports. Design Qualification (DQ.). I More...

Responsibilities: Providing statistical programming support to generate tables listings and figures for assigned projects. Demonstrating proficiency in CDISC SDTM and ADaM to support various submission activities including IA CSR DSUR and publications. Overseeing all aspects of stati More...

Responsibilities: In this role as a Manufacturing Engineer you will focus primarily on releasing new products into addition you will play a key role in developing new manufacturing processes and implementing process controls. Your responsibilities will include but are not limited to More...

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 More...

Job Description: This section focuses on the main purpose of the job in one to four sentences. Technical lead for DHF structure within sustaining engineering for disposable medical devices. Responsibilities: This section contains a list of primary responsibilities of this role that More...

Job Description: The Protein Sciences group collaborates with drug discovery project teams across client therapeutic areas including Oncology Immunology and Neurology. Our group enables project teams with antigen protein reagents. We are seeking a cell culture / molecular biology sci More...

Job Description: We are hiring Commissioning and Qualification (C&Q) Engineers at both mid-level and senior levels to join our team in Raleigh NC. These roles involve ensuring the successful commissioning and qualification of utilities and process equipment for pharmaceutical manufact More...

Responsibilities: Lead clinical data management activities for multiple complex studies from study startup to database lock and final reporting. Develop and manage data management timelines for multiple projects ensuring all milestones are met according to project plans. Design build 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: 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...

Job Description: We are seeking an experienced Compliance Specialist to support enterprise-scale vulnerability remediation OS upgrade projects and infrastructure compliance across lab and manufacturing environments. This role demands a solid understanding of regulated IT environments More...

Responsibilities: Author technical reports policies and Standard Operating Procedures. Author/review format and revise reports protocols analytical method validations and CMC sections for regulatory submissions. Author investigations deviations change controls and other non-conforman More...

Job Description: The Quality Engineering Manager will lead all Quality Engineering activities and incoming quality issues. Ensure all quality related systems of the plant are established and documented to provide a safe and effective product. Build sound technical and organizational c More...

Job Description: Responsible for the management and coordination of engineering activities related to CIP (Cleaning in Place) and SIP (Sterilization in Place) with external partners and internal stakeholders. Responsibilities: Review CIP/SIP design. Develop and implement CIP/SIP stra More...

Responsibilities: Team provides customized real-world data and real-world evidence solutions to address the most important research questions across clinical development market access and commercial use cases for our life sciences partners. Independently translate analytic specificat More...

Roles & Responsibilities: Walk through production lines understand equipment and production processes. Understand the current state information from site leaders and functional managers. Understand current challenges and projects in place to improve performance. Understand the projec More...