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...
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 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 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 conta...
Roles & Responsibilities: Supports the overall QMS processes for the organization. Responsible for activities required to ensure compliance of Quality Management Systems (QMS), specifically regarding CAPA, complaints and internal/external...
Job Summary: A leading organization is seeking an experienced Validation Engineer to support validation strategy, compliance, and qualification activities for digital solutions in a GMP-regulated environment. Roles and Responsibilities: ...
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 : 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...
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...