- Legend Biotech USA, Inc. (Raritan, NJ)
- …the candidate have experience working in an aseptic manufacturing facility, preferably in quality assurance , manufacturing compliance , clinical quality , ... and Preventive Actions (CAPA) process and is responsible for ensuring compliance within quality systems processes.Key Responsibilities Provide oversight to… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …the candidate have experience working in an aseptic manufacturing facility, preferably in quality assurance , manufacturing compliance , clinical quality , ... process validation, shipping validation, and data integrity.Key Responsibilities Provide quality and compliance oversight for computer systems validation,… more
- Insmed Incorporated (San Diego, CA)
- …of Clinical Quality Assurance (CQA) serves as a strategic leader managing quality and regulatory compliance related to GCPs, acts as quality lead on ... for potential use and provides direction, guidance and strategy for company Quality Assurance .Full understanding of and practical experience establishing and… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …ensuring highest quality to patients. This role enables and ensures compliance against health authority regulations and Novo Nordisk requirements in relation to ... applicable Develops comprehensive, relevant resources (eg training program, FAQs) to enable compliance with quality control process requirements across NNI and… more
- Aequor (Thousand Oaks, CA)
- …graduates without industry experience will not be considered. This position supports 's Quality Assurance program under the Plant QA organization providing daily ... compliance issues, providing recommendations, and assuring progress of quality records to completion. The Sr. Associate will also...will also represent functional area for the Drug Substance Quality Assurance department in the execution of… more
- Eisai, Inc (Nutley, NJ)
- …difference. If this is your profile, we want to hear from you. Director, Clinical Quality Assurance The Director, Clinical Quality Assurance position is ... delivery and execution of the North America (NA) Clinical Quality Assurance (CQA) strategy including audit and...Good Clinical Practice (GCP) oversight, and for assuring the compliance of projects, products and programs with Eisai's Standard… more
- Merck & Co. (Rahway, NJ)
- …performance of team members, fostering a collaborative and innovative team environment.Regulatory Compliance and Quality Assurance :Ensure that all activities ... launch in alignment with the company's business goals, and quality and regulatory compliance .-Essential Duties and Responsibilities:Strategic Leadership… more
- Repligen (Waltham, MA)
- …issues through appropriate channels, ensuring long-term risk mitigation and product quality assurance .Qualifications Bachelor's degree in engineering, Quality ... team. You will a key role in ensuring the quality , compliance , and performance of Repligen's global...in supplier quality engineering, manufacturing engineering, or quality assurance . Proven experience with ISO 9001… more
- Merck & Co. (Rahway, NJ)
- …for SDTM Conversions.Demonstrated success in the assurance of deliverable quality and process compliance .Excels in technical writing, able to convert ... process and providing tools and templates to support delivery focusing on traceability, quality assurance , data conformance and data fitness. The position is a… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …and in a manner which meets their expectations Coordinates and collaborates with Quality Assurance function to maintain a COE for deviation management covering ... find better and more innovative ways to improve their quality of life. We're changing lives for a living....chain and customer focus. This role enables and ensures compliance against health authority regulations and Novo Nordisk requirements… more
- Aequor (Thousand Oaks, CA)
- …new technologies and ensure smooth integration into new and/or modified processes Regulatory Compliance and Quality Assurance : Ensure all data management ... and reporting including knowledge of Pinnacle 21, Centralized Statistical Monitoring, Quality by Design, Risk-based Quality Management etc. Determine key… more
- Repligen (Waltham, MA)
- …the biotechnology industry. This leader will be responsible for managing the site quality assurance team which includes all day-to-day activities for product ... meetings with the Senior Management team.Facilitate operational excellence initiatives in Quality Assurance .Maintain internal and external audit schedules; serve… more
- Merck & Co. (North Wales, PA)
- …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
- Merck & Co. (North Wales, PA)
- …Skills and Experience: Demonstrated success in the assurance of deliverable quality and process compliance . Strong working knowledge of reporting processes ... management concepts Experience in CDISC and ADaM standards Experience ensuring process compliance and deliverable quality Strategic thinking - ability to turn… more
- BioAgilytix (Durham, NC)
- …with hands-on responsibility for data quality , access control, and compliance protocols.Define standards, build quality assurance processes, and ... a focus on operational efficiency and data integrity. Data Quality & Compliance Automation: Use Robotic Process...systems.Proven ability to define data standards, develop and implement quality assurance processes, and ensure data integrity… more
- Eisai, Inc (Raleigh, NC)
- …Eisai Raleigh facility. This position is responsible for executing core quality assurance functions, supporting regulatory inspections, and collaborating with ... QA Specialist plays a critical role in ensuring the quality and compliance of commercial and clinical...and/or Biologics is a plus). Demonstrated experience across applicable quality assurance functions in a GMP setting… more
- Merck & Co. (Durham, NC)
- …Manufacturing Processes, Operations Support, Pharmaceutical Production, Pharmaceutical Quality Assurance , Production Operations, Production Scheduling, ... Safety, Health, Environment and Quality (SHEQ), Safety Procedures, Shift Work, Standards Compliance... Quality (SHEQ), Safety Procedures, Shift Work, Standards Compliance , Systems Troubleshooting {+ 3 more}-Preferred Skills:Job Posting End… more
- Repligen (Hopkinton, IA)
- …and make real-time adjustments to meet production targets.Inspect products for quality assurance and report defects or inconsistencies.Communicate effectively ... will play a key role in ensuring that the department's safety, quality , and production goals are met.ResponsibilitiesSupervise and coordinate the activities of… more
- Twist BioScience (South San Francisco, CA)
- …MES professionals, primarily software developers, who work in concert with Manufacturing Operations, Quality Assurance , and R&D. The Director will serve as the ... closely with the platform architecture and infrastructure teams, Manufacturing Operations, Quality Assurance , Process Development, and Regulatory Affairs teams… more
- Tris Pharma (Monmouth Junction, NJ)
- …coordinates and advances required documentations, in liaison with Product Development (PD)/ Quality Assurance (QA)/ Quality Control (QC)/Regulatory Affairs, ... Response Letters (CRLs)Cleans, maintains and calibrates laboratory instruments to ensure compliance with current Good Laboratory Practices (cGLPs) and cGMPs; Cleans… more
