Job Description: The GMP Asset Mechanic is responsible to ensure that GMP production assets are evaluated prior to purchase, qualified and documented as needed, maintained and commissioned prior to use, and properly decommissioned and stor...
Responsibilities: Effectively designs and codes SAS programs using BASE/SAS, SAS/STAT, SAS/GRAPH and SAS MACROS for assigned clinical projects(s) Produces and delivers CDISC and regulatory compliant SDTM, and ADaM standard datasets. Cre...
Responsibilities: Leads all DM lifecycle activities, from study start-up, maintenance, database lock and close-out. Independently develop DM documents including but not limited to Data Management Plans (DMP), Case Report Forms (CRFs), CR...
Job Description: The Associate, Regulatory Affairs Submission Management, manages low to medium impact submission projects involving multiple cross-functional regulatory submission teams. With input from the submission teams, this individu...
Job Summary : The Senior CSV Engineer – Project Lead is responsible for leading and executing Computer System Validation (CSV) activities for GxP-regulated systems, with a strong focus on Electronic Batch Record (EBR) platforms. This role ...
Responsibilities: The primary job responsibility for this position is overseeing the day-to-day functions of the Dentsply Sirona Essential Dental Solutions team This role develops regulatory strategies for existing, new, and modified med...
Roles & Responsibilities: Develop a deep understanding of global Rapid Diagnostics distribution processes, systems, and business programs to identify operational risks, inefficiencies, and opportunities for improvement. Lead the creation...
Job Description: The Manufacturing Associate I is responsible for supporting the production of therapeutic proteins (Active Pharmaceutical Ingredients - API) under strict cGMP conditions. This entry-level role involves executing manufactur...
Roles & Responsibilities : Monitor due dates for lab instrument reviews and coordinate with stakeholders. Execute SOP-driven validations, produce IQ/OQ/PQ deliverables, and ensure ALCOA+data integrity. Perform gap analyses, remedi...
Roles & Responsibilities: Ensure compliance with GMP, GLP, and GDP requirements across manufacturing and quality operations. Review and approve SOPs, protocols, batch records, and other controlled quality documents. Lead and support dev...