- Legend Biotech USA, Inc. (Raritan, NJ)
- …that would provide reduction in COGs, increase throughput, capacity and quality compliance .Provide technical expertise in automation projects from user ... in the treatment of multiple myeloma.Legend Biotech is seeking Sr. Investigator Compliance Specialist as part of the Technical Operations team based in Raritan,… more
- Merck & Co. (Rahway, NJ)
- …and result in outcomes that demonstrate the Company's dedication to regulatory compliance .Ensures that a cross-functional team (eg Quality & Continuous ... level sites that require a Company headquarters input.Other activities:Provides input into GCP Quality and Compliance Council regarding the QMS, RACT, Quality… more
- Repligen (Waltham, MA)
- …growing Supplier Quality team. You will a key role in ensuring the quality , compliance , and performance of Repligen's global supplier base. This is an ... Notifications (SCNs)Evaluate and manage Supplier Change Notifications to ensure compliance with internal and regulatory quality standards.Coordinate… 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
- 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
- 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
- Legend Biotech USA, Inc. (Raritan, NJ)
- …operation in a controlled cGMP cleanroom environment. This position is responsible for quality and maintaining the highest standards in compliance within company ... reagents.Strive to reduce non-conformances in supported areas by proactively driving compliance .Support Investigations team by providing quality and … more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …external audits, and high impact projects, fostering s culture of excellence and compliance and working toward building a quality mindset with Medical ... the respective business areas.Responsibilities:Leadership and Project Management:Lead the end-to-end quality execution across Medical Affairs programs, ensuring compliance… more
- Aequor (Fort Worth, TX)
- …monitoring for production. Conducts and analyzes in-process and final product quality analyses/inspection in compliance with standards and regulatory ... Job Description: Job title: Associate I, Quality Control Lab - Microbiology Location: Fort Worth,...responsible for maintaining lab equipment and reagent preparation and quality . Maintain supplies/stocks needed by production team. Ensure that… more
- Insmed Incorporated (San Diego, CA)
- …and implementation of EDC systems to support clinical trials, ensuring data quality , compliance , and efficiency throughout the study lifecycle. The AD, ... comply with GCP, 21 CFR Part 11, and CDISC ODM StandardsData Quality & Compliance :Ensure EDC systems comply with regulatory requirements (eg, FDA, EMA, ICH-GCP)… more
- Merck & Co. (North Wales, PA)
- …the entire product lifecycle for the assigned projects. Assure deliverable quality and process compliance .Responsible for effective deliverable development ... CDISC and ADaM standards and demonstrated success in the assurance of deliverable quality and process compliance also required.Must possess broad knowledge and… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …on preventing failures (increasing availability), but also on increasing EHS & QUALITY compliance or reducing costs (without reducing availability). He/she ... failures (increasing availability), but also on increasing EHS & QUALITY compliance or reducing costs (without reducing availability). He/she monitors the… more
- Merck & Co. (Durham, NC)
- …during tours to provide area/process overview information to visitors/auditors upon request-- Quality & Safety Compliance - Foster strong safety culture on the ... reporting safety issues and completing corrective/preventative actions-Drive culture of compliance through actions, consistent quality -driven decision making,… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …of CAR-T drug product for human use. This position is responsible for quality and maintaining the highest standards in compliance within company policies, ... supervisory activities for designated team members.Support Investigations team by providing quality and compliance input for continuous improvement; and… more
- Merck & Co. (Rahway, NJ)
- …and Manufacturing divisions.Interface with external suppliers and partners to ensure the quality and compliance of components used in Autoinjectors, driving ... expertise in the design, development, and manufacturing of Autoinjectors, ensuring compliance with industry standards and regulatory requirements (eg, ISO 13485, FDA… more
- Merck & Co. (Durham, NC)
- …and implementation of new systems which enhances the operation and/or engineering processes. Quality & Safety Compliance :The successful candidate should be able ... make our products. We work in the manufacturing plants with a "Safety First, Quality Always" mindset striving for continuous improvement. We work in the local plant… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …an SME during the execution of regulatory inspections and audits as needed.Support compliance activities for site Quality Operations in accordance with Legend ... candidate has experience working in an aseptic manufacturing facility, preferably in quality assurance, manufacturing compliance , clinical quality , or cell… more
- Merck & Co. (Millsboro, DE)
- …leaders and frontline teams, and who works effectively across functional partners. Quality - and compliance -focused with practical experience supporting regulatory ... Integrated Process Team that directly influences site performance, product quality and cost-of-goods for life-changing animal vaccines. Your leadership will… more
- Merck & Co. (Rahway, NJ)
- …principal scientist will be expected to exhibit a mindset of safety and quality compliance , which will include following current Good Manufacturing Practices ... consider qualified applicants with arrest and conviction records for employment in compliance with the San Francisco Fair Chance Ordinance Los Angeles Residents… more
- Merck & Co. (Rahway, NJ)
- …sustained launch in alignment with the company's business goals, and quality and regulatory compliance .-Essential Duties and Responsibilities:Utilize extensive ... activities are conducted with the highest regard for safety, quality , and regulatory compliance , aligning with the...highest regard for safety, quality , and regulatory compliance , aligning with the company's divisional and local site… more
