Responsibilities: The SAS/Statistical Programmer will also be responsible for ensuring the accuracy and consistency of clinical data. The successful candidate will work closely with the Biostatisticians, Data Managers, and Clinical Resea...
Job Summary: Lead process design efforts from modeling through to pilot scale and qualification, including technical reviews. Drive process and product characterization to ensure rigorous technical understanding meets scale-up metrics a...
Summary: ​The SDTM Database Programmer is part of the Data Sciences group and is focused on SDTM programming...
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...
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...
clinical development life cycle Compile, coordinate and review applications to Regulatory Authorities including...
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 ...
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...
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...
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...