- Merck & Co. (Durham, NC)
- …Organization, will independently manage Shop Floor Quality Assurance team on second shift. Lead a Shop Floor QA team to provide end-to-end QA support ... product, including biotech culture growth, harvest, lyophilization, product inspection, and quality control laboratories.The Quality Assurance Manager will… more
- Merck & Co. (Rahway, NJ)
- …one or more functional areas such as quality assurance , laboratory, manufacturing, production, equipment/facilities management , regulatory. Good ... include but are not limited to the following: Perform quality assurance activities related to API (including...audits, inspections, and CAPAs. Support quality risk management activities as facilitator, project lead and/or… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionReporting to the Director of Medical Device and Combination Product Quality Assurance , the Associate Director Quality Engineering & Quality ... (ISO 14971) and other worldwide regulations and requirements. This position provides Device quality engineering, quality assurance support and leadership to… more
- Merck & Co. (Rahway, NJ)
- …deviation management , and Corrective/Preventative Actions (CAPAs)Previous background in quality control, quality assurance , auditing, or regulatory ... Job DescriptionQuality Assurance Specialist (Hybrid) The mission of Quality Assurance is to safeguard the rights and well-being of patients; comply with… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …with the Global RD/PV QA team.RESPONSIBLITIESProgram oversight: Support the Global Quality Lead (s) (GQLs) and Regional Quality Leads (RQLs) by ... a perpetual state of compliance as follows:Support the Global Quality Lead (s) (GQLs) and Regional Quality...in the US, in collaboration with the Global RD/PV QA team. May be assigned other Inspection Management… more
- Exela Pharma Sciences, LLC (Lenoir, NC)
- …SummaryThe Quality Director is the senior leader and decision maker for the Quality Department and Quality Management System. This position is ultimately ... standards. This position is the decision maker for the Quality Management System deployed throughout the company....company performance.Must set the expectation for the company in quality mindfulness and lead by example. Must… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …organization working closely with local, regional and global stakeholders across the Quality Assurance organization and with members from different business ... Director, GMP QA Process Excellence is accountable to collect information, analyze quality related process, define strategies to lead to the development and… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …pack out of final product material.Develop positive relationships with the QA team, Quality Control, Information Technology, Maintenance, Manufacturing ... Site Leadership Team members, and peers.Independently makes appropriate and compliant GMP decisions. Lead the establishment and improvement of QA practices to… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Executive Administrative Assistant to provide comprehensive support to leaders and members of GMP Quality Assurance team and will serve as the primary point of ... advanced skills in technology systems, including word processing software and data management software, and business emailing software as well as intermediate skills… more
- Merck & Co. (Durham, NC)
- …aspects of the project proceed in compliance with cGMP, regulations, and our Company's Quality Management System. Provide QA shop floor support in the ... Job DescriptionPosition Description: Specialist, Quality Assurance 1st Shift - Our...simulation batch records. Perform Quality retain sample management activities, if applicable. Lead Shopfloor audits… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …for GxP and Non-GxP systems and services. In this position, the GSM will lead major incident calls, conduct problem management meetings, and drive process and ... supporting and participating in regulatory agency inspections, partner audits, and QA inspections preferred- Veeva Quality Docs Vault, Valgenisis, Trackwise… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …and updates Study Supply Plans in close communication with CSO project Management Lead .Responsible for the Clinical Label Development process which includes ... This role is primarily responsible for supporting CSO Project Management Leads by developing and updating Study Supply Plans,...the packaging Batch Record review and approval process with Quality Assurance and other CSO personnel.Works closely… more
- Tris Pharma (Monmouth Junction, NJ)
- …Manager, Quality Management Systems (QMS) supports, oversees and manages the Quality Assurance ( QA ) Investigations and Product Quality Complaints ... risk management principles in the design (and resolution) of key quality management system elements to ensure complianceTracks and trends deviations and… more
- Exela Pharma Sciences, LLC (Lenoir, NC)
- …plans for staffAssist in the performance of Media Fills with input from Quality Assurance , Validations, and Operations This position may be involved with ... Position SummaryThe QC Microbiology Group Lead will report directly to Microbiology management...leadership in building, leading and developing a group of quality control microbiologists that support the ongoing development, manufacture,… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Affairs, Quantitative Clinical Pharmacology, Clinical Safety and Pharmacovigilance, Regulatory/Risk Management , Quality Assurance , Medical Affairs, ... Research, Research, Informatics Services, Project Management and Operational Management . The Tech Lead must have the ability to develop a strong, positive… more
- AUROBINDO (Dayton, OH)
- …consists of an experienced management team with expertise in manufacturing, R&D, Quality Assurance and Quality control and regulatory affairs. In ... Data required for Regulatory filings.Serves as department representative and/or technical lead at meetings. May lead and coordinate day-to-day activities… more
- Merck & Co. (Rahway, NJ)
- …with numerous stakeholders such as , Clinical Research Associates, Statisticians, Quality Assurance , and Regulatory Affairs to drive data excellence ... are seeking a highly qualified and experienced Associate Director in Data Management to lead our data management team in supporting the pharm and… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …or equivalent experience required 8+ years of operations, quality assurance , call center, compliance, project management , operations and/or other related ... Program Management team to ensure vendor compliance with all quality /safety requirements; educates on process requirements Partners with compliance and Program … more
- Twist BioScience (South San Francisco, CA)
- …Engineering, Biomedical or Biological Sciences, or a related field.10+ years of experience in quality assurance or customer service, with at least 5 years of ... We are seeking a highly experienced and motivated Staff Quality Engineer join our dynamic team. As a Staff...experience in a supervisory or management role.Proven ability to lead and manage… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- … Management process. Through careful coordination with stakeholders and consistent quality assurance , minimize the risk of changes, strive for uninterrupted ... rare diseases and immune disorders. Summary The ITSM Process Manager for Change Management is responsible and accountable for managing and maintaining the IT Change … more
