Job Description: This role will be heavy on execution and technical writing - so just need someone with some familiarity in process validation and who is comfortable learning new equipment and executing. Requirements: BS Degree in Engin...
Responsibilities: Manage end-to-end delivery of data management services concurrently for single/multi-service projects with little-to-no guidance, ensuring quality deliverables on time and within budget to customer satisfaction Provide ...
Summary : Develop qualification plans for supplier transfer projects and complete associated verification testing. Manage and execute Engineering Change Requests (ECRs) and Engineering Change Orders (ECOs). Roles & Responsibilities: C...
Summary: Provides technical and quality system guidance related to establishing product software as a medical device requirements. Provide quality oversight for product software as a medical device verification and validation activities ...
Responsibilities: Participate in the development of the CMC regulatory strategy for small molecules These submissions include health authority briefing packages, IND/CTA, NDA, and MAA regulatory filings. Prepare and review CMC submissio...
Role Overview: The Product Quality Engineer (PQE II) will support product engineering and the Quality Management System, leading investigations, supporting change controls, and ensuring compliance with FDA, ISO, and internal quality system...
Job Description: Regulatory Affairs Specialist II with working knowledge of FDA, and CE marking requirements for IVD products. Client is currently transitioning from IVDD to IVDR (In Vitro Diagnostic Regulation). The RAS is responsible for...
Seeking an experienced CMC Writer / Project Manager to support regulatory submissions and ensure timely, high-quality documentation for global health authorities. This role combines technical writing expertise with project management skill...
Responsibilities: The Sr. Statistical Programmer supports the Biostatistics team in the generation and validation of analysis datasets and statistical outputs for clinical trials This role is key to implementing programming standards and...
Roles & Responsibilities: Lead smoke studies, including airflow visualization and identifying stagnant air or pass-through airflow issues. Support pressurization challenge studies and evaluate what happens during loss of differential pre...