guidelines and company quality policies. Requirements: Bachelor's degree in Pharmaceutical Sciences, Life Sciences, Chemistry...
multiple priorities. Requirements: Bachelor's degree in quality management, Regulatory Affairs, Life Sciences, or a related...
and continuous improvement. Extensive CSV expertise in life sciences, especially patient safety. Proficiency in Argus Safety, Veeva...
as needed. Qualifications: Bachelor's degree in engineering, Life Sciences, or a related field. 5-8 years of experience in validation...
Qualifications: - Providing the validation strategy for different computer systems in life sciences industry...
documentation. Requirements: B.S. or equivalent in computer science, mathematics, or life science. A minimum of 5 years...
Responsibilities: Draft and implement Quality System documentation designed to establish good validation practices within the organization. Author URS, IQ, OQ and PQ protocols and execute them in compliance with GDP guidelines and intern...
Responsibilities: Developed and optimized efficient, cost-effective, and validated manufacturing processes for medical devices, focusing on capital and/or disposable devices, including assembly, lot release testing, sterilization, and pac...
Roles & Responsibilities: Bachelor of Science in Lifesciences or master's Preferred. 3-5-year experience level. In vitro primary cell culture (human PBMC, Cyno PBMC and mouse splenocyte). Serial dilutions of drug molecules and applicat...
Responsibilities: Lead the strategic efforts in the interpretation of relevant and new quality guidelines to ensure that the current and phase appropriate requirements and standards are properly and timely implemented. Provide support to...
Overview: The Genomics Research Canter (GRC) is a centre of excellence for genetics and genomics that supports both Discovery and Development. The GRC plays an integral role towards our goal of developing extraordinary genetics and genom...
Responsibilities: Processes, proofreads, verifies and manages various clinical regulatory documents, ensuring they are submission-ready for publishing with an appropriate level of accuracy and consistency. Communicates regularly with col...
Responsibilities: Strong Windows Desktop Support Experience. Hands-on experience in handling the Parma LAB devices and instruments. Desktop Hardware and troubleshooting at L2 + (Window 10, 7). Experience in handling IT Desktop ...
Responsibilities: The role requires strong US, EU, China, and international regulatory experience that can be leveraged to help support international expansion. This is a hybrid role (in office 3 days per week) based in Marlborough, MA. ...
Roles & Responsibilities: The ideal candidate will have 7-8 years of validation experience and at least 3 in Salesforce Validation. Seeking a CSV resource who has experience specifically with Salesforce. They are currently seeking a Sr....
Responsibilities: He/she is expected to have the potential to be the analytics lead for the assigned therapeutic area (TA) to mitigate, resolve and triage certain issues and reduce the touch point needed from the study lead. Responsibili...
Responsibilities: Responsible for managing end-to-end CSV deliverables for both new & existing applications. Draft documents, QA Review of the following CSV Deliverables: User Requirements, SOPs Application Administrative Tasks & Protoco...
Responsibilities: Responsible to communicate new regulatory guidelines. Lead the strategic efforts in the interpretation of relevant and new quality guidelines to ensure that the current and phase appropriate requirements and standards ar...
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), C...
Responsibilities: Client collaborates with world-class hospitals in the Boston area to turn cutting-edge medical research into usable, meaningful products. The Sr. Manufacturing Engineer will have high collaboration between R&D, Pilot, ...