Roles & Responsibilities: Plan, develop, and implement QA standards, inspection, and testing procedures. Support manufacturing operations to ensure product quality and compliance. Lead failure investigations, root cause analysis, and CA...
Responsibilities: Collect, enter, and manage clinical trial data using electronic data capture (EDC) systems. Perform data validation and query management to ensure data quality and compliance with study protocols. Assist in the develop...
Job Description: We are seeking a skilled Electrical Engineer (PCB Design) to join our engineering team in Holyoke, MA. In this role, you will be responsible for the end-to-end design and development of multilayer printed circuit boards (P...
Responsibilities: Responsible for providing guidance to ensure that all regulatory submissions are planned, communicated, and performed per regulatory and business requirements. In addition, this position serves as a subject matter expert...
Responsibilities: To support the Biostatistics team by carrying out programming activities of statistical programmers and overseeing external vendors (as required), and to ensure timely and accurate programming and validation activities f...
Job Description: Must Have Radiopharmaceuticals and Quality experience. All others will not be considered. *** The RPT QA Auditor is responsible for planning, conducting, and reporting on internal and external audits to ensure compliance...
Job Description: Responsible for manufacturing and assembling clinical and commercial products. Operates production equipment. Weighs, measures and checks raw materials to ensure batches manufactured contain proper ingredients and quantiti...
Responsibilities: Lead and manage reliability improvement projects within operations and engineering. Author and review Change Control and Quality documents related to product or process modifications. Maintain operational compliance wi...
Responsibilities: Serve as the technical SME for qualification of analytical equipment in manufacturing setup. Author and execute qualification protocols (URS, DQ, IQ, OQ, PQ) in accordance with GAMP 5, FDA 21 CFR Part 11, and EU Annex 1...
Job Description: We are seeking a Controls Engineer to join our on-site team in Birmingham, AL. The ideal candidate will have hands-on experience with automation systems, PLC programming, and motion or vision control. You will be responsib...