Job Description: The Manufacturing Associate is responsible for producing therapeutic proteins (Active Pharmaceutical Ingredient - API) under cGMP conditions. This role involves executing process recipes, following Standard Operating Proce...
Job Summary: We are seeking a skilled professional to lead and execute Infrastructure Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) documentation for AWS-hosted environments. This role is critical...
Summary : Proficiency in CAD (Solid Works Creo), GDT, tolerance analysis, and fixture design. Knowledge of orthopedic testing standards (ASTM F382, F543, F1717, F2077, ISO 1424214243, etc.). Strong capability in test protocol report wri...
Summary: ​The SDTM Database Programmer is part of the Data Sciences group and is focused on SDTM programming and custom programming in elluminate, a repository and visualization tool. The SDTM Database Programmer is responsible for the d...
Summary : The Quality Engineer is responsible for maintaining quality and control of manufacturing processes and post-market performance of medical devices. Responsibilities include collaborating with internal and external stakeholders to...
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, ...
Responsibilities: Lead part qualification activities by driving the APQP/PPAP process, evaluating and validating supplier manufacturing processes to ensure the delivery of high-quality, cost-effective, and reliable parts that meet design ...
Summary Proficiency in CAD (SolidWorksPTC Creo), GDT, tolerance analysis, and fixture design. Strong capability in test protocol report writing, statistical analysis (9595, tolerance intervals), and data integrity practices. Familiarity...
Roles & Responsibilities : Documentation Management. Review and verify manufacturing Batch Production Records (BPRs) to ensure compliance with internal specifications, cGMP regulations, and ISO 13485 guidelines. Review production schedu...
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 ...