- Merck & Co. (Durham, NC)
- …provide input to the deviation investigation process for determination of root cause , recommend corrective actions to prevent re-occurrence and help assess the ... equipment, process, and people) in order to best understand and identify root cause and then fix then fix implement corrective and preventative actions to prevent… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …investigations batch release metrics targets. Drive batch impacted investigations to root cause to meet critical release windows. Provide technical expertise to help ... identify true root cause of investigations and assess product quality impact.Work closely...up to determine if corrective actions adequately addressed root cause of NC event.Identify potential compliance issues and opportunities… more
- Merck & Co. (Rahway, NJ)
- …building housekeeping, and consumable inventory. - Provide input for incident root cause analysis, reporting, and action items. - Facilitate and drive building ... Technologies, Production Efficiencies, Production Scheduling, Raw Material Sampling, Root Cause Analysis Training, Safety Protocols, Shift Work {+ 4 more}-Preferred… more
- Novo Nordisk Inc. (West Lebanon, IN)
- …Actively participate on cross functional teams to determine the root cause and corrective actions for problems associated with investigations Completes accurate ... broad understanding of Concepts of Validation Change control processes Root cause analysis techniques and cGMP documentation practices cGMP regulations, GMP and… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …identified, this role will be responsible for conducting root cause analyses, documenting/tracking associated CAPAs or process deviations, and coordinating ... coordinating with relevant process owners and cross-functional SMEsConduct root cause analyses for any issues identified, to define CAPAs/deviationsMaintain a… more
- Eisai, Inc (Exton, PA)
- …assigned.Creates and updates deviation management processes (including investigations and root cause analysis) and procedures for GxP systems as assigned.Creates and ... through insightful solutions that address complex issues. Ability to dissect root cause of issues creating the best solution for Eisai considering quality, cost,… more
- Twist BioScience (South San Francisco, CA)
- …QC dataInvestigate product/process/quality issuesReview of CAPAs, process deviations, root cause analysisPreparation of product and process quality reports by ... collecting, analyzing, and summarizing information and trendsWrite/review product quality documentationFollow regulatory and ISO 13485 requirementsWhat You'll Bring to the Team BS/MS in Biochemistry, Chemistry, Molecular Biology or related field2+ years… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …limited to Deviations/Investigations, Out of Tolerances (OOTs), Change Controls, Root Cause Analysis and FMEA'sDemonstrates willingness to learn new skills as ... requiredAvailable for other duties as requiredSupport tracking and achievement of annual maintenance goals and objectives including metric improvement targets. Support continuous improvement activitiesEnsure site compliance with all local, state and federal… more
- Repligen (Waltham, MA)
- …external auditors, regulatory agencies, and industry peers.Operational Excellence:Lead root cause analyses for identified control deficiencies and oversee the ... development and execution of effective remediation plans.Ensure that all compliance-related activities are documented, tracked, and aligned with the company's overall risk management strategy.Evaluate and implement new tools, technologies, and methodologies to… more
- Novo Nordisk Inc. (Durham, NC)
- …documentation required Excellent troubleshooting skills with ability to identify root cause of problem required Demonstrated knowledge of critical controls & ... (hypothesis testing, sampling, trending, etc.) a plus Expert in utilizing appropriate root- cause analysis tools & techniques a plus Experience with Risk Assessment &… more
- Novo Nordisk Inc. (Durham, NC)
- …&/or lead the closure of investigations per approved timeframes using root cause analysis & systematic problem-solving techniques Participate in teams to help ... At least one (1) year of demonstrated experience using root- cause analysis techniques to solve problems preferred Organization/Planning: Demonstrated expertise… more
- Merck & Co. (Rahway, NJ)
- …Product Risk Management, Quality Management Systems (QMS), Risk Management, Root Cause Analysis (RCA) {+ 2 more}-Preferred Skills:Job Posting End Date:06/11/2025 *A ... job posting is effective until 11:59:59PM on the day BEFORE -the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date. Requisition ID:R351271 more
- Aequor (Thousand Oaks, CA)
- …requests per established SOP and processes. 6) Lead technical root cause analysis, incident investigations, and troubleshooting on process control issues related ... to mechanical, electrical, instrumentation and control systems. 7) Support new product introductions or new technology introductions by performing engineering assessments, implementing automation system configuration changes and supporting engineering runs. 8)… more
- Repligen (Waltham, MA)
- …Implementation of corrective actions to solve problems based on root cause analysis Develop and own Process Improvement projects.Qualifications Engineering degree or ... equivalent required 5-7+ years of engineering experience in a manufacturing or product development environment Demonstrated track record of successful project execution Excellent presentation, verbal, and written communication skills Experience with the… more
- Aequor (Athens, GA)
- …maintenance of technical data and support documentation Participate in root cause analysis and implement corrective and preventative actions to address problems; ... escalation of production flow disturbances Demonstrate a visible and tangible commitment to EHS (Environment, Health, and Safety) programs and initiatives Assessment of individual performance in regard to the continuous improvement (AAI) Participate and… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …for improvement. Responsible for continuous process improvement identified through root- cause analyses engaging other support teams as needed Ensures payroll ... compliance with Company Policies, Federal, State, Local, International regulations, and Sarbox Responsible for creating and maintaining payroll guidelines and written instructions for payroll policies and procedures Support the year-end payroll process with… more
- Merck & Co. (Lower Gwynedd, PA)
- …relative to their role.A problem solver/troubleshooter, skilled in Root Cause Analysis (RCA).#eligibleforerpCurrent Employees apply HERE Current Contingent Workers ... apply HERE US and Puerto Rico Residents Only:Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities. Please click here if you need an accommodation during the application or hiring… more
- Novo Nordisk Inc. (West Lebanon, IN)
- …and direct support to manufacturing teams, conduct deviation investigations, root cause analysis, validations for new equipment installs, and other tasks helping ... our manufacturing operations succeed day to day. This role will work closely with different functional groups accross the site for projects including: Manufacturing, MSAT, QA, and other engineering teams. This is an onsite based role 5 days a week… more
- Aequor (Tampa, FL)
- …and system failures and determines or supports determination of root cause and recommends/performs corrective actions and preventative measures. Manages and issues ... equipment tooling, ensuring that tools are maintained properly, tracked, kitted for use, and available. Coordinates and performs equipment relocation ensuring no damage is incurred during the move and that asset is fully functional and within specification… more
- Aequor (Cincinnati, OH)
- …of any OOS and aberrant results Actively participate in root cause problem solving during laboratory investigations, provide input for effective corrective ... and preventive actions Perform routine maintenance on lab equipment, as needed Perform peer review of laboratory testing, as required Basic knowledge and understanding of USP, cGMP, and FDA regulations Create and maintain lab record documentation (notebooks… more
