cGxPServe

Job Description: We are seeking to add top talent to our Materials Support team. The Material Handler performs operations of the Supply Chain/Materials Management department with awareness and knowledge of the various areas of the operations in Goods Receipt Goods Issue Warehousing In المزيد...

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 المزيد...

Responsibilities: Maintains all qualified and validated equipment and systems in compliance with policies guidelines and procedures. Develops protocols and associated reports while adhering to a change management process. Supports the execution of equipment qualifications and validat المزيد...

Responsibilities: Support clinical trial applications submitted via Clinical Trial Information System (CTIS) uploading documents Qin documents uploaded to ensure accurate categorization. Track CTIS application details to compile metrics Monitor CTIS notifications received due dates a المزيد...

Responsibilities: Lead the development validation and documentation of CDISC-compliant SDTM and ADaM datasets for CNS clinical trials ensuring traceability from raw data through analysis outputs. Program and QC tables listings and figures (TLFs) for interim and final clinical study r المزيد...

Responsibilities: The role includes obtaining and maintaining regulatory approvals supporting quality management system (QMS) objectives and ensuring adherence to applicable regulatory standards. The Regulatory Affairs position is responsible for global product registrations and ensu المزيد...

Responsibilities: Conduct statistical programming and analysis of clinical research studies. Provide programming support for publication efforts and regulatory submissions. Manage the timely creation review completion and delivery of statistical programming activities and deliverable 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...

Roles & Responsibilities: GMP Experience. Minimum 8 years in a GMP-regulated biopharmaceutical environment. Quality Assurance Experience . At least 2 years specifically in a QA role. QA Compliance Knowledge. Strong knowledge of QA Compliance systems including. Quality Management Revi المزيد...

Responsibilities: Develop implement and maintain software quality assurance processes for non-product software used in medical device development. Ensure adherence to regulatory standards (FDA ISO 13485 IEC 62304) and industry best practices for non-product software. Support audits المزيد...

Responsibilities: Responsible for filing necessary applications and handling all government interactions pertaining to the regulation process for products requiring governmental approval. Authoring and submitting PMA supplements (30-day Notice Real-Time Reviews 180-Day Supplements An المزيد...

Job Description: We are seeking a Product Development Tech for our Brea CA facility. This person contributes to the completion of routine technical tasks and develops solutions to routine technical problems of specified scope. Their contacts are primarily with immediate supervisors pr المزيد...

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 المزيد...

Responsibilities: The Senior SAS Programmer will be responsible for statistical programming for the clients clinical studies. In this role you will develop and validate SAS programs for data presentation analyses and provide programming support to project team members. Our Ideal cand المزيد...

Responsibilities: Serve as the principal programming lead across multiple studies or a clinical program ensuring timely accurate and regulatory-compliant deliverables. Lead or contribute to the development validation and documentation of SDTM ADaM and TFLs in support of clinical stud المزيد...

Responsibilities: The Regulatory Affairs Manager is responsible for the development and execution of global regulatory strategy and tactical planning for assigned microbiology on market products or those products in development. Assures that defined regulatory strategies defined are المزيد...

Job Description: This document outlines the employment prerequisites and job responsibilities for the Supplier Quality Associate II position. This position has primary responsibility for driving overall quality performance throughout the supply chain. Specific responsibilities includ المزيد...

Job Description: We are seeking a motivated and detail-oriented contractor to support in vitro immunology assays within our group. The ideal candidate will assist with various aspects of T cell and dendritic cell functional assays including sample preparation flow cytometry and data h المزيد...

Job description: This position provides support and drive for activities that support the overall long-range plan ensuring the department/functions continues to be competitive and meets all required cost compliance and customer service needs and commitments over this horizon. The proj المزيد...

Job Description: Drive verification and validation in software/hardware testing for medical device products. This role is critical to ensuring the quality and reliability of products by leading test strategy planning execution and automation efforts. The Test Lead will collaborate cl المزيد...