- Merck (West Point, PA)
- …development through commercialization, with practical insight into how these operations generate CMC regulatory content + Understanding of CMC operations, ... source systems to regulatory documentation. Under the guidance of dCMC Regulatory Authoring Leadership, the Senior Specialist , Regulatory Authoring Data… more
- Guidehouse (St. Louis, MO)
- …Ability to Obtain Public Trust We are currently searching for a Quality Assurance Specialist to provide support to the US Food & Drug Administration in the following ... other established guidelines for the Chemistry Manufacturing and Controls ( CMC ) Review Process. + Coordinate the resolution of OPQ...Will Need** **:** + A bachelor's degree in Life Sciences or a relevant field such as Quality Assurance,… more
- Parexel (PA)
- …are looking to fill a **Scientist 2 or 3 - Analytical Chemist Metrology Specialist ** position working as a full-time employee of Parexel FSP on long-term assignment ... position does not offer sponsorship** . **The Analytical Chemist Metrology Specialist is responsible for the oversight of regulated and non-regulated laboratory… more
- Merck (West Point, PA)
- … regulatory documentation. Under the guidance of dCMC Leadership, the Senior Specialist , Digital CMC Data Analyst, will support development and implementation ... and supply. A key workstream within this initiative is the auto-generation of regulatory filing sections, enabled by a dedicated application designed to create a… more
- ERP International (Cherry Point, NC)
- …ERP International, LLC:** ERP is a nationally respected provider of health, science , and technology solutions supporting clients in the government and commercial ... Maintain adherence to the Joint Commission, URAC, CMSA, DHA and other regulatory requirements. Apply medical care criteria (eg, InterQual). * Establish cost… more