- Merck & Co. (Rahway, NJ)
- …culture by reducing waste and constantly driving continuous improvement. Responsible to review and approve compliance documents, as per procedures or ... Improvement, Engineering Standards, Equipment Maintenance, Estimation and Planning, GMP Compliance , Management Process , Manufacturing Processes, Manufacturing … more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …and gene therapy manufacturing processes. This role combines deep expertise in CAR-T process technologies with a strong focus on compliance auditing, risk ... conduct internal audits, support regulatory inspections, and lead investigations to ensure process integrity and GMP compliance . Additionally, the role includes… more
- Merck & Co. (Durham, NC)
- … process control, data collection techniques, and troubleshooting in compliance with SDLC, GMP, safety, and environmental regulations.- Actively support, ... Data Management, Environmental Regulations, Environment Health and Safety, GMP Compliance , Management Process , Manufacturing Processes, Problem Management,… more
- Merck & Co. (Rahway, NJ)
- …and operational experience to lead and support facility operations, process development activities, compliance investigations/change management, authoring of ... through participation in equipment design and testing as well as preparation, review , and completion of GMP documentation. Support compliance with Industrial… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Affairs QA to conduct quality reviews of product profiles, ensuring thorough management review of all quality and compliance topics, including Key Quality ... through appropriate forums, such as Quarterly Quality Reports (QQRs) and Quality Review Boards (QRBs).Collaborate with business process owners to monitor the… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …indicating data and identifying trends.Contribute to maintain investigation compliance metrics.Support investigation process improvement initiatives.Job duties ... during the execution of regulatory inspections and audits as needed.Support compliance activities for site Quality Operations in accordance with Legend standards,… more
- Merck & Co. (Millsboro, DE)
- …our Millsboro Senior Leadership team and lead a high-impact Integrated Process Team that directly influences site performance, product quality and cost-of-goods ... and deliver measurable results.What you own: Lead and grow the Integrated Process Team (IPT) - coach managers and individual contributors, build capability, and… more
- Merck & Co. (North Wales, PA)
- …decisions on requirements and design topicsSupport functional areas in identification and review of process questions and issues related to submission content ... Business Operations Lead is expected to understand the end-to-end regulatory submission process . The main focus will be on document production processes, including… more
- Eisai, Inc (Nutley, NJ)
- …creation and submissions including compliance & IT/security assessments; procurement process ; and creation, review and tracking of requisitions and purchase ... distribution lists and sending communications/ uploading shared files as needed Review monthly medical social media channel content calendars Coordinate domestic as… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …oversight of all aspects of the cell therapy clinical manufacturing process .Support manufacturing activities for cGMP compliance through spot checks/internal ... runs that are conducted to support manufacturing to ensure sterility of the product/ process is not compromised.Support batch review & material release in SAP… more
- NVA (Yuma, AZ)
- …both in the moment and via the structured annual review process . Develops and monitors hospital-specific client compliance protocols and procedures. ... exceptional medical care to our patients, leading the decision-making process for medical protocols, staffing, manage associate veterinarians, assuring regulatory… more
- Merck & Co. (Rahway, NJ)
- …the ability to assimilate technical information, and a commitment to quality and compliance in a regulated environment.- - Key responsibilities: - Enter, review , ... and submit individual case safety reports for assigned products- Prepare and review aggregate adverse event reports and maintain aggregate report schedules- Support… more
- Merck & Co. (Millsboro, DE)
- …biosafety programs and policies to ensure a safe working environment in compliance with local, state, and federal regulations. The Sr. Specalist of Biosafety ... Associate Director of Safety & Environment at Millsboro, DE.Responsibilities:Ensure compliance with internal and external biosafety regulations and guidelines… more
- Merck & Co. (Rahway, NJ)
- …Compliance , Interpersonal Relationships, Lean Six Sigma (LSS), Management Process , Manufacturing, Manufacturing Process Validation, Operational Excellence, ... efficiency while instilling a culture grounded in safety & compliance .Key ResponsibilitiesCollaborate with formulators, engineers, site partners, and other… more
- NVA (Sulphur, LA)
- …both in the moment and via the structured annual review process .. Develops and monitors hospital-specific client compliance protocols and procedures.. ... leadership for the hospital, managing associate veterinarians, and assuring regulatory compliance relating to the practice of veterinary medicine. The Managing… more
- Merck & Co. (North Wales, PA)
- …both commercial and research matters, and will collaborate closely with other Compliance functions, as well as ex-US legal counterparts, to ensure global alignment ... (eg, patient support programs, digital health, innovative partnerships), and AI initiatives.Draft, review , and negotiate privacy terms for a wide array of contracts,… more
- Merck & Co. (Rahway, NJ)
- …Execute Good Manufacturing Practices (GMP) activities such as release, stability, and in- process testing of Biologics Drug Substance (DS) and Drug Product (DP) using ... organized manner following ALCOA principals and SOPs. - Author and review technical documents. Complete assigned work within established project timelines. Support… more
- Merck & Co. (Rahway, NJ)
- …compliance audits, inspection activities, and investigation/CAPAs.-- Author and review technical documents. Complete assigned work within established project ... Execute Good Manufacturing Practices (GMP) activities such as release, stability, and in- process testing of Biologics Drug Substance (DS) and Drug Product (DP). Act… more
- UNC Health (Chapel Hill, NC)
- …of weakness, research causes and formulate recommendations that enhance operations and compliance . Familiarizes self with area under review , and if necessary, ... health and well-being of the unique communities we serve.Summary:Responsible for assisting Compliance management in all compliance activities which could include… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …records review and completeness of all associated documentation ensuring compliance with written Policies and procedures as required for batch releasePerform ... First Quality review for executed batch records dailyPerform other assigned duties...to support OOS, Deviation, and CAPA logsReview of specific in- process , and finished product data such as eLims samples… more
