- Insmed Incorporated (San Diego, CA)
- …Director of Clinical Quality Assurance (CQA) serves as a strategic leader managing quality and regulatory compliance related to GCPs, acts as quality ... cross functional working groups to identify and mitigate GCP quality and compliance issues.Supports the evaluation and acceptability of vendors for potential… more
- Repligen (Waltham, MA)
- …audit schedules; serve as host for site auditsMaintain risk-based strategy for overall Quality compliance across the organization and in support of the ISO ... - Quality Network Leader, Chromatography & Proteins.ResponsibilitiesThe Director, Quality will be responsible for:Maintaining site compliance to ISO 9001… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …and Preventive Actions (CAPA) process and is responsible for ensuring compliance within quality systems processes.Key Responsibilities Provide oversight to ... systems records.Support CAPA site governance programDrive continuous improvement of quality systems processes.Ensure compliance with current Good Manufacturing… more
- Syneos Health Careers (Morrisville, NC)
- Description Quality and Compliance Assessor - Clinical Monitoring Excellence (Remote, 75% Travel, East & West Coast Roles) Syneos Health(R) is a leading fully ... to create a place where everyone feels like they belong. Job Responsibilities Quality and Compliance Assessor - Clinical Monitoring Excellence (Remote, 75%… more
- BioAgilytix (Durham, NC)
- …a foundational data governance framework, with hands-on responsibility for data quality , access control, and compliance protocols.Define standards, build ... with a focus on operational efficiency and data integrity. Data Quality & Compliance Automation: Use Robotic Process Automation (RPA) tools like UiPath or… more
- Aequor (Cincinnati, OH)
- …needed Monitoring chemical and dry stock inventory Assist with ordering chemicals/materials COMPLIANCE AND QUALITY Basic knowledge and understanding of USP, ... Quality Control Analyst I Does the position allow for the worker to be virtual/remote? No Temp to Perm: Temp to perm based on openings and performance Shift… more
- Novo Nordisk Inc. (West Lebanon, IN)
- …strict adherence to cGMPs, established manufacturing practices and procedures, and compliance with quality regulations and guidelines. This position carries ... your potential? The Position This position has primary responsibility to support Quality Control operations in the microbiology, analytical or inspection area. This… more
- Eisai, Inc (Raleigh, NC)
- …to hear from you. The QA Specialist plays a critical role in ensuring the quality and compliance of commercial and clinical products manufactured at the Eisai ... Raleigh facility. This position is responsible for executing core quality assurance functions, supporting regulatory inspections, and collaborating with internal and… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …focused on an EHS first mindset, a Right First Time culture of quality , permanent inspection readiness compliance mindset and passionately drives continuous ... the facilityPartner and manage relationships with contractors to ensure quality of work and compliance with all...contractors to ensure quality of work and compliance with all company policies and regulatory guidelinesHelps improve… more
- Merck & Co. (Rahway, NJ)
- …The scientist will be expected to exhibit a mindset of safety and quality compliance , which will include following current Good Manufacturing Practices (cGMPs), ... -The candidate will provide scientific expertise by learning and utilizing Quality Risk Management methodologies and tools for statistical design of experiments.… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …process validation, shipping validation, and data integrity.Key Responsibilities Provide quality and compliance oversight for computer systems validation, ... of systems, instruments, and equipment used at the site.Develops and evaluates quality processes and system standards to ensure compliance with applicable… more
- Merck & Co. (Rahway, NJ)
- …Metrology Equipment, Personal Initiative, Pharmaceutical Management, Pharmacy Regulation, Quality Auditing, Regulatory Compliance , Reviewing Literature {+ ... Analytical Research & Development (AR&D) External Capabilities, Validation, and Compliance (ECVC) department of our company's Research Laboratories Division is… more
- Merck & Co. (Rahway, NJ)
- …launch in alignment with the company's business goals, and quality and regulatory compliance .-Essential Duties and Responsibilities:Strategic Leadership ... of team members, fostering a collaborative and innovative team environment.Regulatory Compliance and Quality Assurance:Ensure that all activities are conducted… more
- Merck & Co. (Rahway, NJ)
- …Python Programming for SDTM Conversions.Demonstrated success in the assurance of deliverable quality and process compliance .Excels in technical writing, able to ... global human health.Responsibilities: The Senior Statistical Programmer, Submission Data Standards Quality Management (SDS QM), provides oversight and quality … more
- Twist BioScience (South San Francisco, CA)
- …analytics, and data visualization capabilities to support operational decision-making and quality reviews. Compliance & Validation: Ensure our custom MES ... across our biomanufacturing operations. This critical role will drive efficiency, quality , and robust data integrity within a highly automated environment. The… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …would provide reduction in COGs, and increase throughput, capacity, and quality compliance .Work cross-functionally across Technical Operations and interface with ... with alignment to Global Procedures.Act as a Site MES SME to support Quality Investigations, Corrections, and QMS records.Build the Site Readiness of MES for FDA… more
- Merck & Co. (North Wales, PA)
- …in CDISC and ADaM standardsDemonstrated success in the assurance of deliverable quality and process compliance .Strategic thinking - ability to turn strategy ... that project plans are executed efficiently with timely and high quality deliverables.For assigned projects the position serves as the statistical programming… more
- Mondelez International (Richmond, VA)
- …our Mission to Lead the Future of Snacking. Make It With Pride. The Quality and Regulatory Compliance Manager ensures effective deployment of MDLZ risk-based ... Provision; Know Your Rights: Workplace Discrimination is Illegal Job Type Regular Supply Chain Quality Assurance Product Quality , Safety and Compliance more
- Carrie Rikon & Associates (Great Neck, NY)
- Food Quality Assurance and Document Compliance Specialist 75K Plus Benefits Work Onsite 5 Days A Week Great Neck, NY Wholesale Food and Beverage Company is ... seeking a skilled FSQA Compliance Specialist, with experience evaluating document compliance ...This position will work within the Food Safety and Quality Assurance Department, in the East Coast Headquarters, with… more
- Merck & Co. (North Wales, PA)
- …management concepts Experience in CDISC and ADaM standards Experience ensuring process compliance and deliverable quality Strategic thinking - ability to turn ... Preferred Skills and Experience: Demonstrated success in the assurance of deliverable quality and process compliance . Strong working knowledge of reporting… more
