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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 More...

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 More...

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 More...

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 More...

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 More...

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 More...

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 More...

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 More...

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 More...

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 More...

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 More...

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 More...

Job Description: As a Quality Engineer for New Product Introduction (NPI) at Stryker you will provide technical leadership for quality assurance and control activities throughout the product lifecycle. You will lead initiatives related to risk management (pFMEA) process validation sup More...

Job Description: We are seeking a highly motivated Scientist to join the Immunology Department. Our team is focused on identifying new targets for the treatment of autoimmune and chronic inflammatory diseases through computational analysis of human disease tissue derived datasets and More...

Job description: We are looking for a highly motivated scientist to join our Exploratory Biologics group in Discovery Research Immunology. The position offers a unique opportunity for a talented scientist to work in a dynamic innovative and multi-disciplinary environment to develop th More...

Responsibilities: Technical expert that will independently investigate identify develop and optimize new methods/ techniques to address critical project needs. Continuously seek to improve existing laboratory methods and processes. Read and adapt literature to accomplish assignments. 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: Author and execute Master Validation Plans (MVPs) OQ (Operational Qualification) and PQ (Performance Qualification) protocols and reports in compliance with regulatory and internal standards. Lead validation activities for critical manufacturing processes including: More...

Responsibilities: Candidate should be able to design and perform cellular assays including siRNA knockdown cell proliferation and activation screening assays. Prior primary cell culture experience is required with experience in qPCR Western ELISA and flow cytometry preferred. Requir More...

Job Description: Our client is seeking an experienced Cleaning Sterilization Engineer to lead autoclave validation activities in a dynamic regulated manufacturing environment. This role is highly hands-on focusing on executing sterilization protocols developing cycles and providing tr More...