- Insmed Incorporated (NJ)
- …Director, Patient Services Quality & Process leads quality assurance and process improvement initiatives to ensure compliance, consistency, and ... Process is responsible for overseeing the quality monitoring, process management, and continuous improvement efforts that support Insmed's patient… more
- Merck & Co. (Durham, NC)
- Job DescriptionWe're looking for a Director of Quality Assurance to lead quality across the full value chain for a late-stage ophthalmic program. In this ... manufacturing excellence from development through commercialization. You'll partner across Quality , Regulatory, Technical, and Supply Chain teams-coaching, facilitating, and… more
- Novo Nordisk Inc. (Durham, NC)
- …the two NNPILP Emerging Technologies (ET) sites, which includes responsibility for the Quality Assurance (QA) function and serving as the leading expert in ... ensuring compliance with all regulatory requirements and maintaining the highest standards of quality assurance within the organization Participate as member of … more
- Formation Bio (New York, NY)
- …documentation. Foster a culture of continuous improvement and development within the quality assurance team, ensuring that all team members have the support ... are seeking a highly accomplished, strategic Vice President of Quality Assurance . In this pivotal role, you...teams to implement corrective and preventive actions. Lead the quality review process , ensuring the effective review… more
- Insmed Incorporated (NJ)
- …to clinical manufacturing.Drive Quality input into lifecycle changes, process optimizations, and continuous improvement initiatives across development ... degree (MS, PhD, PharmD) strongly preferred.Minimum of 15 years of relevant Quality Assurance experience in the biopharmaceutical industry, including at least… more
- Merck & Co. (Millsboro, DE)
- Job DescriptionThe Senior Quality Specialist ensures product/ process quality system adherence and batch record review, completes quality checks and SAP ... within a team environment. Primary Responsibilities - Provides direct Quality support for Integrated Process Team (IPT)...to the biologics field or a related area - Quality assurance audits or inspection of vaccine… more
- Novo Nordisk Inc. (Boulder, CO)
- …Position Oversee the CMC QA Organization for the site, which includes responsibility for the Quality Assurance (QA) function and serves as the leading expert in ... compliance with all regulatory requirements and maintaining the highest standards of quality assurance within the organization Participate as a member of… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …candidate have experience working in an aseptic manufacturing facility, preferably in quality assurance , manufacturing compliance, clinical quality , or cell ... (CAPA) process and is responsible for ensuring compliance within quality systems processes.Key Responsibilities Provide oversight to the CAPA program for the… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …candidate has experience working in an aseptic manufacturing facility, preferably in quality assurance , manufacturing compliance, clinical quality , or cell ... for Legend's Quality Management Review (QMR).Support management of the Quality Management Review (QMR) program.Support continuous improvement efforts through… more
- Butterball (Raeford, NC)
- …turkey, the brand represents more than 60 years of cherished memories, providing quality , great tasting products that make meals something to celebrate every day.We ... turkey, the brand represents more than 60 years of cherished memories, providing quality , great tasting products that make meals something to celebrate every day. We… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …of Microsoft Office.Experience in quality metrics reporting, analysis and process improvement techniques is a plus.Proficient with using Microsoft Office ... the candidate has experience working in a cGMP manufacturing facility, preferably in quality assurance , manufacturing compliance, clinical quality , or cell… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …identifying trends.Contribute to maintain investigation compliance metrics.Support investigation process improvement initiatives.Job duties performed may require ... candidate has experience working in an aseptic manufacturing facility, preferably in quality assurance , manufacturing compliance, clinical quality , or cell… more
- Cipla (Central Islip, NY)
- …implement improvements, create/revise relevant SOPs. Participate in site and corporate quality and process improvement initiatives. Represent QA ... The QA Validation Associate role is responsible for providing Quality Assurance support for receiving/ releases GMP...performance metrics for Batch Review and Release Contributes to process improvement of batch records and associated… more
- Merck & Co. (North Wales, PA)
- …Maintenance Management, Oncology, Periodic Reports, Pharmaceutical Management, Process Improvement Projects, Process Improvements, Quality Management, ... programs.Support the global regulatory lead in label development.Assisting with process improvement initiatives.Performing regulatory administrative activities as… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …or risks are addressed with continuous improvement initiatives.Work directly with business process owners to integrate quality into all stages of process ... GxP Quality representatives, and act as the Quality Assurance point person for all GxP... Indicators (KQIs). Identify and drive initiatives for continuous quality improvement .Deputize for the Sr. Director, Medical… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …have relevant working experience in an aseptic manufacturing facility, preferably in quality assurance , manufacturing compliance, clinical quality , technical ... supported areas by proactively driving compliance.Support Investigations team by providing quality and compliance input for continuous improvement and… more
- Cipla (Hauppauge, NY)
- …non-conformance issues, supports supplier management, and contributes to continuous process improvement . Responsibilities: Ensure proper storage, handling, and ... compliance and per GMP requirement. Report, escalate to Manager quality assurance about daily shop floor activities...and want to ensure that our hiring and interview process meets the needs of all applicants. If you… more
- Merck & Co. (Rahway, NJ)
- …standards (eg, FDA, cGMP), maintain optimal environmental conditions for product quality , and support continuous operations. The ideal candidate will have strong ... reports to senior management on HVAC system status, risks, and improvement initiatives.Responsibility for developing and managing operating expense within approved… more
- Cipla (Central Islip, NY)
- …Work closely with internal stakeholders, including global procurement, R&D, manufacturing, quality assurance , supply planning and finance teams, to understand ... with company objectives. Lead efforts to identify opportunities for cost savings, process improvements, and risk mitigation. Develop, manage and monitor RFQ (Request… more
- Cipla (Fall River, MA)
- …implement procedure as per Current Good Manufacturing Practices (cGMP) guidelines by Quality Assurance (QA). Check and monitor for cleanliness, maintenance, ... is preferred. Minimum of two to three (2-3) years' experience in quality assurance in a cGMP pharmaceutical manufacturing operation environment. Technical… more
