- Novo Nordisk Inc. (West Lebanon, IN)
- …Performs walk-through audits of NNUSBPI Manufacturing facilities Releases product based on Quality Assurance record review and approval by Manager, Quality ... experience in a pharmaceutical or biotechnology company with one (1) year direct Quality Assurance experience Knowledge, Skills, and Abilities: Ability to work… more
- Novo Nordisk Inc. (West Lebanon, IN)
- …or a leading international regulatory agency preferred As applicable, experience with Quality Assurance oversight and support for all phases of Clinical and ... records. Will be a QA presence on the manufacturing floor. Relationships Quality Assurance . Essential Functions Reviews all manufacturing and support records… more
- Aequor (West Greenwich, RI)
- …Role supports quality management systems, office based, EW will be supporting recall regulatory reporting 50% of their time and other projects for the QMS ... zones. What are the exact shift hours/schedule the contractor will be working/ reporting ? Mon-Friday standard business hours 8-5 PM What is the working environment… more
- Aequor (Swiftwater, MN)
- …with 2&plus years Regulatory Affairs experience OR Master's degree in Regulatory Affairs/ Quality Assurance or an appropriate combination of other ... Overview of the Position The Regulatory CMC Specialist will work closely with the...contribute to Critical Process Analysis and Testing Strategies Organizational Reporting and Communication: Responsible for reporting on… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …other research relevant duties under the RDPV QA function to ensure that Quality assurance oversight are being addressed and managed appropriately. Ability to ... with expertise in: oncology, biologics or vaccines.Must have proven expertise within Quality Assurance Research to support Global Research QA including… more
- Eisai, Inc (Nutley, NJ)
- …and concisely in both verbal and written format.Excellent documentation and reporting skills to meet legislative, regulatory , and corporate ... responsibilities from both the strategic and execution perspectives for Eisai. Reporting directly to the Executive Director, IT Security, Compliance, & Architecture,… more
- Merck & Co. (North Wales, PA)
- …to anticipate stakeholder requirements.Preferred Experience: Demonstrated success in the assurance of deliverable quality and process compliance. Strong ... art scientific methodologies and tools to enable the discovery, development, regulatory approval, manufacturing, and marketing of medical drugs and vaccines for… more
- Novo Nordisk Inc. (Boulder, CO)
- …our patients Work effectively across all departments, such as Quality Assurance / Control, Chemical Development, Program Management, Regulatory , Quality ... to support analytical and process development, the CMC team works alongside Quality , Regulatory , Technical Operations and RNAi Early Development professionals at… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …timely remediation.SOP Authorship and Review Maintain a close working relationship with Quality Assurance and participate in the Company Global SOP Committee. ... year' experience in pharmaceutical or biotechnology development functions or clinical quality assurance required Experience Qualifications Experience:10 or More… more
- Merck & Co. (North Wales, PA)
- …management conceptsExperience in CDISC and ADaM standardsDemonstrated success in the assurance of deliverable quality and process compliance.Strategic thinking - ... art scientific methodologies and tools to enable the discovery, development, regulatory approval, manufacturing, and marketing of medical drugs and vaccines for… more
