- ThermoFisher Scientific (Plainville, MA)
- …assisting with GMP manufacturing and warehouse operations + Ensure inspection readiness and regulatory compliance across all site quality systems + Lead all ... in advanced therapies. You'll provide operational quality oversight and ensure compliance and inspection readiness in-line with global regulatory standards-while… more
- Danaher Corporation (Vista, CA)
- …a team of clinical study managers, driving strategic operational execution, ensuring regulatory compliance , and achieving key milestones for critical clinical ... + Ensure studies are conducted in accordance with ICH-GCP guidelines, regulatory requirements, standard operating procedures (SOPs), and study protocols. + Manage… more
- Charles River Laboratories (Charleston, SC)
- …Ability to develop expertise in LAL product formulation, testing methods, regulatory documentation, SOPs, and associated computer systems and software tools. ... required. * Maintain currency in all training, SOPs, cGMP, and regulatory requirements. * Monitor in-process product formulations for quality control, potency,… more
- Charles River Laboratories (Shrewsbury, MA)
- …management, interpretation, and reporting of study data and assuring the regulatory compliance of these projects, as appropriate. Additional responsibilities ... in accordance with company standard operating procedures and industry regulatory guidelines. This position will serve as the primary...in the direction and execution of assigned studies in compliance with regulations as they apply to the conduct… more
- Bristol Myers Squibb (Princeton, NJ)
- …of audit programs by observing and participating in audits to assess regulatory compliance . + Use data analytics to generate business-relevant reports. ... Safety, Regulatory Affairs, and Medical Affairs activities. + Evaluate the compliance of processes and policies with regulatory requirements. + Support the… more
- WuXi AppTec (Middletown, DE)
- …(RCA) or other similar reliability based protocols on all equipment failures ** Regulatory Compliance & Documentation** + Maintain accurate records of all ... maintenance, and reliability of all utilities, facilities, and grounds for our pharmaceutical manufacturing facility in Middletown DE. This role is responsible for… more
- Jacobs (Cary, NC)
- …interpersonal relations and personnel management skills * Working knowledge in applicable regulatory compliance , as well as all applicable federal, state and ... support Life Sciences North America (LSNA) an upcoming large/mega pharmaceutical project ($1B+) in the NC, IN, or TX...it relates to the continuous improvement of HSE practices, compliance to corporate initiatives, and legal and regulatory… more
- Amgen (New Albany, OH)
- …calibration/electrical systems and technical cleaning systems are maintained in compliance with all applicable industry standards, regulatory standards ... part in the coordination of tech support on engineering, regulatory , compliance , calibration, quality, microbial/environmental, technical cleaning, validation,… more
- Lilly (Lebanon, IN)
- …subject matter expert for assigned HSE programs and serve as an HSE regulatory advisor for manufacturing and support units. **Key Responsibilities for this role ... startup plans while ensuring decisions meet project deliverables and compliance requirements, leveraging existing Lilly knowledge, and incorporating external… more
- Sanofi Group (Swiftwater, PA)
- …quality control, and data management. **Deliverable Accountability:** + Ensure compliance with GMP and regulatory standards, including user/functional/detailed ... teams to ensure alignment of automation systems with production goals and regulatory requirements. ** Compliance & Risk Management** **:** + Ensure that… more