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...
Job Summary: Medical Device Quality Engineer responsible for supporting the launch of a new medical device product into production at an onsite manufacturing facility in Devens, MA. The role focuses on process validation, risk managemen...
Responsibilities: This role is responsible for Regulatory Affairs support of submissions and ongoing regulatory compliance for product development process and sustaining engineering projects, ensuring compliance with FDA and EU regulation...
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...
in biotechnology, pharmaceuticals, or lifesciences manufacturing. Roles & Responsibilities: Production Operations: Operate...
Responsibilities: Lead data management activities as a program-level lead data manager in support of Alnylam clinical studies. Lead database build activities including leading cross-functional review of eCRF content, review of edit check...
+principles. Qualifications: Bachelor's degree in pharmacy, LifeSciences, Chemistry, or a related field. 5+years...
Roles & Responsibilities: Provides analytical support in Project Management under minimal supervision. Supports the Project and Program Review meetings including information gathering across all projects, meeting operations, and manage m...
Responsibilities: Participate in the development of the CMC regulatory strategy for small molecules. These submissions include health authority briefing packages, IND/CTA, NDA, and MAA regulatory filings. Prepare and review CMC submissio...
Job Description: This position is responsible for efficient and effective performance of sampling raw materials and testing (except for the raw materials chemicals) in conformance with regulations and standards. Responsibilities: Mainta...