- Daiichi Sankyo, Inc. (Bernards, NJ)
- …guidance to teams during the development and execution of Corrective and Preventive Actions (CAPAs) including timely escalation of critical issues, tracking of ... guidance to teams during the development and execution of Corrective and Preventive Actions (CAPAs) including timely escalation of critical issues, tracking of… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …context of Quality Investigations (QI's). He/she supports CAPAs (Corrective and Preventive Actions) and CCs (Change Controls) within quality management systems. You ... the Asset / Reliability Engineer monitors and evaluates the performance of the preventive maintenance plan. In the event of changing operating conditions, you take… more
- Aequor (Fort Worth, TX)
- …met for our products and processes. Key Responsibilities: Perform instrument preventive maintenance, performance verification per schedule and per standards/SOPs as ... needed. Perform instrument trouble shooting, support investigation per standards/SOPs as needed. Write or review validation protocols and technical reports. Review internal documents / external documents, make recommendation as needed. Collect, calculate,… more
- Tris Pharma (Monmouth Junction, NJ)
- …Investigations/OOS/OOT/Lab Event, Product Quality Complaints (PQCs), Corrective Action Preventive Actions (CAPAs) and Continuous Process Improvements (CPIs)Works ... directly and cross functionally throughout company (ie, QA Operations, Quality Control (QC), Manufacturing, Operations, Technical Services, Senior Leadership, etc.) on deviations and PQC investigations relating to production operations, quality operations… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …CAPAs and to ensure the timely completion of corrective and preventive actions within the laboratories.Provide recommendations for the improvement of processes ... and requests.Reporting/Monitoring metrics on non-conformance investigations and corrective and preventive actions (CAPA).Perform tasks in a manner consistent with… more
- Novo Nordisk Inc. (West Lebanon, IN)
- …audits of NNUSBPI Manufacturing facilities Review and assess Corrective and Preventive Actions Reviews and approves validation documentation Reviews and assesses ... deviations; includes tracking, follow-up and reporting/trending Reviews manufacturing and support records to certify compliance with specifications and procedures Works closely with Manufacturing and Quality Control to resolve open issues resulting from record… more
- Merck & Co. (Durham, NC)
- …of complex automated process equipment.Identify spare parts for preventive maintenance plans.Interface with other departments, contractors and disciplines ... on scheduling repairs and maintenance of clean utility systemsAssists with execution of automation, validation and additional testing, as requiredResponsible for written documentation of activitiesEfficient and safe maintenance and repair of equipment using… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …early identification of issues and discrepancies, creates mitigation strategies, preventive actionsSupports development of Dx product portfolio under design and ... change control regulations (ISO 13485, ISO 20916, IVDD/IVDR, and QSR). Supports analytical and clinical utility validation of candidate clinical biomarkers used for patient selection and treatment monitoring. Drives additional prevalence and body of evidence… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …sessions, identifying potential quality issues and proposing suitable solutions fostering a preventive mindset across the team and to the organization based on the ... metrics collected.- Development of Standards and Procedures (SOPs) and Training: Liaise with GMP areas to ensure adequate procedural documents directly impacting area of responsible and/ or other GMP areas as assigned. Responsible to adhere and implement key… more
- Merck & Co. (Durham, NC)
- …safety, and environmental regulations.- Review and approve automation documents, preventive maintenance, and SOPs to ensure compliance with Good Manufacturing ... Practices and safety.Leads investigations of automation incidents and problems to prevent recurrence including the development and implementation of corrective actions.Evaluates automated and information technology systems, and develops strategies to optimize… more
- Exela Pharma Sciences, LLC (Lenoir, NC)
- …good scientific understanding of these techniquesPerform instrument troubleshooting and preventive maintenance as neededPerform investigations on studies that have ... unusual results, and on out-of-trend and out-of-specification results.Write, review, and update standard operating procedures and department policies as neededPerform all activities in compliance with cGLP/cGMP requirementsPerform all activities in compliance… more
- Novo Nordisk Inc. (WA)
- …internal and external stakeholders to develop and implement Corrective and Preventive Action Plans (CAPA) Shares information, collaborates and provides relevant ... input and guidance to other areas within NACD, CMR, and Global partners Demonstrates technical proficiency within responsible areas, staying up-to-date on new practices, systems, and technologies while building knowledge of emerging trends and advances within… more
- Novo Nordisk Inc. (West Lebanon, IN)
- …systematic problem-solving tools to resolve deviationsIdentify and initiate corrective and preventive actions for deviations. Ensure adequate CAPAs are put in place ... to reduce or eliminate recurrence of issuesWork without direct guidance and minimal oversight to get results, meet timelines, and improve processesEffectively communicate with peers and colleagues regarding the status of investigations and offer… more
- Lovelace Biomedical Research Institute (Albuquerque, NM)
- …Operator Maintenance Worker III will be responsible for performing preventive maintenance, troubleshooting and repairing central plant equipment. This includes ... heating hot water boilers, steam boilers, centrifugal chillers, air compressors vacuum pumps and associated support equipment. The individual will also assist with plumbing, HVAC repairs and other related duties and tasks as required or… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …associated with the jobPossesses experience and training in reactive, preventive , and predictive maintenance of allmechanical, HVAC and refrigeration. ... plumbing/pipefitting areas with journeyman status in at leastoneReads and interprets blueprints, P&IDs, and drawingsUtilize good documentation practices (GDP) for all work performed on the CMMS system workorders. Completes all other work associated with the… more
- Novo Nordisk Inc. (West Lebanon, IN)
- …Reviews and approves Validation Documentation Reviews and assesses Corrective and Preventive Action Reports Participates in Regulatory Inspections Other duties as ... assigned Performs all job duties and responsibilities in a compliant and ethical manner and in accordance with all applicable healthcare laws, regulations and industry codes Incorporates the Novo Nordisk Way and 10 Essentials in all activities and interactions… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …thoroughly and approved in a timely manner and appropriate corrective and preventive action plans are implemented. Strive to reduce non-conformances in supported ... areas by dedicatedly driving compliance. Perform tasks in a manner consistent with the safety policies, quality systems and cGMP requirements. Other duties will be assigned, as necessary. Key Relationships: Works in a collaborative team setting with quality… more
- BioAgilytix (Boston, MA)
- …calibration as well as routine, scheduled, and unscheduled preventive maintenance.Participating in method development and equipment qualification activities ... as directed by Laboratory Management.Supporting audits, inspections, and assisting in responding to observations, if applicable.Maintaining current knowledge of relevant regulations, standards, guidelines, and MT certification through continuing… more
- Novo Nordisk Inc. (West Lebanon, IN)
- …Number of subordinates with direct/indirect referral: n/a Essential Functions Perform preventive maintenance (PM) of plant Respond to and rectify alarm conditions ... on plant equipment Perform trouble shooting, repair and corrective maintenance (CM) of manufacturing related equipment Develop and maintain a working knowledge of building and process automation systems (BMS and PCS) Interfaces with engineering and/or… more
- CLevelCrossing (Chicago, IL)
- …vendors and subcontractors. Utilizes advanced skills to perform complex preventive maintenance and corrective repair of buildings, industrial systems, vehicles, ... Arranges for subcontractors as needed.Consults with clients to schedule preventive maintenance and other downtime to minimize business interruption and… more
