- Tris Pharma (Monmouth Junction, NJ)
- …and Preventative Actions (CAPAs) and Continued Process Improvements (CPIs), Product Quality Complaints (PQC) documentation , compliance efforts, quality ... Junction, New Jersey, Tris has an immediate opening for a Manager, Quality Management Systems (QMS). Summary:The Manager, Quality Management Systems (QMS)… more
- Merck & Co. (Durham, NC)
- …risk to accommodate the full scope of work. Provide the independent quality approval of key qualification/validation documentation such as policies, procedures, ... data integrity, ALCOA principles, maintenance, and use of computerized systems. Provide Quality Unit review/approval of SDLC documentation . Mentor and provide… more
- Aequor (Bothell, WA)
- …cytometers throughout the site which include laboratory and manufacturing buildings.Support administration of quality and laboratory applications including their ... asset management activities for the support of benchtop equipment and lab and quality systems.Execute and update documentation for the support of benchtop… more
- Aequor (Houston, TX)
- …degree in a related field or equivalent experience. - Proven experience in quality management systems or related administrative roles. - Strong organizational ... Job title - Quality Assurance Analyst I Location - Houston, TX...eye for detail. The role is that of an admin that will be processing requests from various departments.… more
- Aequor (West Greenwich, RI)
- 100% onsite Rhode Island. Admin Shift (7am -3:30pm or 8am -4:30pm) Candidate can select their shift. 8 month duration with possible extension.Ideal: Bachelor degree ... supervision, this position will perform routine procedures to support testing within Quality Control. Tasks may include but not limited to performing sample… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …OEDC leadership with timely submission and compliance of all required DS documentation for quality control/assurance, legal, finance, operational and educational ... development initiatives. The Program Lead will have direct accountability for administrative deliverables, will interact regularly with senior leadership and will… more
- Exela Pharma Sciences, LLC (Lenoir, NC)
- …set-up, operate and monitor equipment of the production line.Complete all required documentation and scheduled quality checks.Monitor stopper bowl, over seal ... manufacture, and distribution of pharmaceutical products in compliance with local Administration . The Manufacturing Associate will rely on experience and judgment in… more
- Tris Pharma (Monmouth Junction, NJ)
- …in-house analytical capabilities, when needed. The incumbent ensures timeline, quality and compliance with applicable Standard Operating Procedures (SOPs)/current ... regulatory packages per International Council for Harmonization (ICH)/Food and Drug Administration (FDA) guidance and provides technical guidance within and outside… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Unit Team culture. Service as a primary contact with Legal and Quality Assurance regarding records Retention and Training Coordination. Demonstration and successful ... budget.- Establishes and maintains internal policies and procedures for administrative activities. Implements work plans and initiatives.- Develop, maintain, and… more
- Merck & Co. (Rahway, NJ)
- …validation, and authoring of regulatory submissions. -Under the general scientific and administrative direction of Director in the CCFS group and working in ... a cross-functional team.-Ensures project results meet requirements regarding technical quality , reliability, schedule, and cost.Monitors performance and recommends schedule… more
- Exela Pharma Sciences, LLC (Lenoir, NC)
- …current Good Manufacturing Practices (cGMP), including Data Integrity and Good Documentation Practices (GDocP) Support Supplier Quality Team with coordination ... The SQE Manager, QA Compliance, is responsible for managing the Supplier Quality Program at Exela ensuring timely completion of associated activities and ensuring… more
- Eisai, Inc (Nutley, NJ)
- …eTMF internal reviews, reconciliation and study file archival Performs detailed eTMF CRO quality check reviews with follow-up for missing documentation under the ... action items Performs eTMF assist with set-up requests and Assists with filing and archiving project documentation in the eTMF within the defined timelines Performs… more
- Merck & Co. (Rahway, NJ)
- …Disclosure Department of the GCTO organization prepares a variety of regulated documentation in support of the clinical development portfolio and compliance in ... compliance with applicable legal requirements (Section 801 of the Food and Drug Administration Amendments Act and the Final Rule for Clinical Trials Registration and… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …immune disorders.Summary Responsible for managing the design, development, optimization and administration of global HCM Platforms and processes. This position will ... relevant advancements to optimize system performance and functionality.- Data Quality , Testing and Release ManagementEstablish and enforce robust data governance… more
- Merck & Co. (Millsboro, DE)
- …of Associate Director.This position will have overall responsibility for oversight and administration of day-to-day operation of the animal facilities as well as for ... (IACUC), and facilitating communication between the Animal Services team and the Quality organization. This position will work in close coordination with other… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …Execution Systems Lead and will be responsible for EBR development and administration at the Raritan site to support production processing while liaising with ... test Plans (CTP), Installation/Operational Qualification (IOQ).Define standardizations and update documentation (eg SOPs, WIs, Technical & Design Specifications, and… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …clinical trial management system, drug labeling, and learning management system. Administration of enterprise job scheduler, Manage File Transfer, Business ... multiple sources of data. Responsible for prioritizing team activities and managing quality of the deliverables. Oversee the support and operations of production… more
- Eisai, Inc (Nutley, NJ)
- …solution/strategy clearly and concisely in both verbal and written format.Excellent documentation and reporting skills to meet legislative, regulatory, and corporate ... achieve objectives and individual tasks within agreed deadlines to agreed quality .Ability to establish and maintain good working relationships with colleagues,… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Pharmacology, Clinical Safety and Pharmacovigilance, Regulatory/Risk Management, Quality Assurance, Medical Affairs, Translational Research, Research, Informatics ... Work with the Enterprise Architecture team to ensure all enterprise architecture documentation accurately reflects the solution architecture and is kept up to date.… more
- Exela Pharma Sciences, LLC (Lenoir, NC)
- …methods in compliance with regulations (ISO 14644, EU Annex 1) Administration of HEPA testing assets Contributes to continuous process improvement efforts ... and HEPA certification experience Proficient use of Asset Management and Quality Systems Strong understanding of industrial instrumentation HVAC, and measurement… more
