- Merck & Co. (Durham, NC)
- …labeling, and laboratories to ensure compliance with company policies, procedures, and regulatory expectations. Be involved in all quality -related activities for ... programs in the principles of computerized systems validation, computer software assurance , and regulatory requirements in validation, data integrity, ALCOA… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …dosing or safety. Basic understanding of professional working environment as well as Quality Assurance and global regulatory requirements such that ... oriented in the execution of processes, as directed by senior staff, playing a supportive role in ensuring adherence...and GCPs and is compliant with domestic and foreign regulatory requirement but may seek support on such items… more
- Exela Pharma Sciences, LLC (Lenoir, NC)
- …process qualification, packaging and labeling. This position will interface with Operations, Regulatory , Quality Assurance , Finance, R&D, Project Management ... Position SummaryThe Sr . Director of Technical Transfer is responsible for...to design processes that ensure compliance to sound scientific Quality by Design (QbD) principles, regulatory agency… more
- Aequor (West Greenwich, RI)
- …(KPI) data to assessing process performance and areas of improvement Alerts senior management of significant quality , compliance, supply and safety risks ... is the working environment for this role? Role supports quality management systems, office based, EW will be supporting...management systems, office based, EW will be supporting recall regulatory reporting 50% of their time and other projects… more
- Merck & Co. (Durham, NC)
- …comprised of fermentation, microfiltration/ultrafiltration, and chromatography steps.- - The Quality Senior Specialist provides expertise in the coordination ... activities supporting the vaccine expansion facility. - Primary Responsibilities: The Quality Senior Specialist will be responsible for comprehensive management… more
- Merck & Co. (North Wales, PA)
- …who supports the Global Regulatory Affairs & Clinical Safety (GRACS) and Quality Assurance (QA) organizations within our Research & Development Division . ... Job Description Position Description: Senior Specialist, Financial Planning & Analysis Our company's...analytical support to our Research & Development Division, Global Regulatory Affairs & Clinical Safety (GRACS), and QA organizations.Forecast… 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
- Tris Pharma (Monmouth Junction, NJ)
- …Manager, Quality Management Systems (QMS) supports, oversees and manages the Quality Assurance (QA) Investigations and Product Quality Complaints Team ... (CPIs)Works directly and cross functionally throughout company (ie, QA Operations, Quality Control (QC), Manufacturing, Operations, Technical Services, Senior … 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
