cGxPServe

Responsibilities: This position is responsible for the preparation of regulatory submissions required to market medical devices in both the U.S. and Europe support of international product registrations and related regulatory affairs activities including execution of procedures and s 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: The Regulatory Manager (RM) provides regulatory strategy and development guidance for optimal conduct of clinical trials regulatory agency meetings orphan designations paediatric planning and accelerated procedures ensuring timely preparation of well organized quali More...

Responsibilities: Leads all DM lifecycle activities from study start-up maintenance database lock and close-out. Independently develop DM documents including but not limited to Data Management Plans (DMP) Case Report Forms (CRFs) CRF Completion Guidelines Edit Checks UAT specificatio More...

Responsibilities: This section contains a list of primary responsibilities of this role that account for 5% or more of the work. The incumbent will perform other duties assigned. Manage new 3rd party supplier documentation strategy for peritoneal dialysis disposable sets. Manage chan More...

Roles & Responsibilities: BS degree with 9 years experience in Supplier quality from aerospace / automobile / medical. Experience in PPAP / APQP and new product development and CAPA. Supplier audits and new supplier onboard. Knowledge of quality tools such as 7 QC tools MSA SPC and O More...

Responsibilities: Provide Quality Engineering leadership for software and hardware product development teams. Responsible for leading design control risk management and other Quality Engineering activities for new product development projects. Establish and nurture strong relationshi More...

Job Description: The chart review is critical and the candidate must have knowledge of reviewing medical records for disease process hanging blood and IV lines as well as critical care. Responsibilities: Responsible for maintaining compliance with FDA AATB international and state reg More...

Responsibilities: Knowledge of application of Regulatory requirement including ISO 13485 FDA and International requirements. Enhanced quality system requirements (QSR) throughout business unit by improving quality process and CAPA Closure. Implementing SICR- Supplier Initiated Change More...

Job Description: Onsite Engineer plans leads reviews and front-ends Design Verification Sustaining Engineering and New Product Development projects as a technical contributor cum project leader and engages in all aspects of product development. Responsibilities: Leads the Design Veri More...

Responsibilities: Ensure compliance to new and changing regulations affecting products and processes including but not limited to QSRs global import/export regulations etc. New product setup and management of related projects. Assist with Supplier audits as needed Collaborates with U More...

Roles & Responsibilities: 12 Years of experience. We are seeking an experienced MES Functional Consultant with strong manufacturing process knowledge and expertise in requirement gathering for MES system implementation. The role will require excellent requirement gathering skills to More...

Job Description: Drives improvement and corrective action in the quality of components sourced from outside suppliers. Provides technical support in the selection of suppliers. Develops acceptance criteria for materials. Monitors supplier performance to drive supplier corrective actio More...

Job Description: The Continuous Quality Improvement Engineer will perform video time studies to baseline the material testing value stream (VS). These testing VS maps will include product testing details from Raw Material Receipt to Product Release from the Georgia Campus and as need 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: 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...

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: Experience in cell therapy/biologic/vaccine manufacturing support tech transfer and validation. The Manufacturing Sciences and Technology Engineer Clinical CAR-T Engineering and Technology Support is responsible for supporting the production of personalized cell ther More...