- Aequor (Houston, TX)
- …Leads error prevention and continuous improvement initiatives based on identified recurring root cause. Serves as the Quality Record (PR) Subject Matter Expert ... Displays ability to gather data from various sources across the site, performance of Root Cause Analysis (RCA) to determine the most likely cause of the deviation… more
- Merck & Co. (Durham, NC)
- …automation, equipment, process, and people) in order to best understand and identify root cause.This position is a 1st shift position with the potential for ... GMP compliant calibration databasesExperience with formal problem-solving techniques, such as root cause analysis (RCA), failure mode effects analysis (FMEA), and/or… more
- Repligen (Waltham, MA)
- …The team plays a key role in driving supplier accountability, supporting root cause investigations, and ensuring Repligen's supplier network meets regulatory and ... audits and supplier quality management. Strong problem-solving skills, including root cause analysis and corrective action methodologies. Proficiency in conducting… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …PV Deviation process, including the drafting of a deviation record with robust root cause analysis utilizing Standard Problem Solving (SPS) methods and strong CAPA ... specialty; pharma experience preferred Specific or technical job skills Strong Root Cause Analysis and CAPA development skills. PV experience/knowledge preferred… more
- Aequor (Houston, TX)
- …Major and Critical process deviations with the aim at identification of root cause, determining Product Quality Impact (PQI) and implementation of corrective actions ... final report. Gathering Data from various sources across the site, performance of Root Cause Analysis (RCA) to determine the most likely cause of the deviation… more
- Merck & Co. (Durham, NC)
- …automation, equipment, process, and people) in order to best understand and identify root cause.This position is a 1st shift position with the potential for ... GMP compliant calibration databasesExperience with formal problem-solving techniques, such as root cause analysis (RCA), failure mode effects analysis (FMEA), and/or… more
- Merck & Co. (Durham, NC)
- …automation, equipment, process, and people) in order to best understand and identify root causeThis position is a 1st shift position with the potential for ... GMP/regulated manufacturing environmentExperience with formal problem-solving techniques, such as root cause analysis (RCA), failure mode effects analysis (FMEA),… more
- Merck & Co. (Rahway, NJ)
- …indicators (KPIs) for HVAC system reliability, energy efficiency, and compliance.Lead root cause analysis and corrective/preventive actions (CAPA) related to HVAC ... system failures or deviations.Monitor and ensure environmental compliance, HVAC system operational reliability, coordination of maintenance programs, system efficiency/cost performance, energy optimization and provide technical support to partners, facility… more
- Merck & Co. (Durham, NC)
- …equipment, process, and people) in order to best understand and identify root cause.Efficient and safe maintenance and repair of equipment using Hazardous Energy ... Control ProceduresRequired to wear personal protective equipment including safety glasses, earplugs, gloves, hard hats, safety harnesses, etc.-Position requires clean room gowning during performance of job dutiesActively supports safety initiatives, including… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …internal/external compliance with requirements/regulations Support, coordinate, and manage root cause analysis, corrective action(s)/preventative action(s) (CAPA) in ... connection with audit and/or inspection responses, and ensure proper implementation across various areas of the business Demonstrate leadership skills via acting as project lead on cross-functional projects in the development and/or implementation of processes… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …non-compliances identified, this role will be responsible for conducting root cause analyses, documenting/tracking associated CAPAs or process deviations, and ... needed, coordinating with relevant process owners and cross-functional SMEsConduct root cause analyses for any issues identified, to define CAPAs/deviationsMaintain… more
- Merck & Co. (Rahway, NJ)
- …Quality Management, Quality Management System Improvement, Reliability Management, Root Cause Analysis (RCA), Strategic Thinking, Technical Leadership, Technical ... Problem-Solving, Technical Writing-Preferred Skills:Maintenance EngineeringJob Posting End Date:08/9/2025 *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… more
- Repligen (Hopkinton, IA)
- …of all Non-Conforming Material.Reject any non-conforming material and support Root Cause Investigations.Good organization skills and Microsoft Office software to ... accurately document and maintain associated paperwork and inspection results in a consistent and timely fashion.Identify and communicate continuous improvement opportunities for the quality program for customers internal and external.Maintain clean and orderly… more
- Merck & Co. (Rahway, NJ)
- …Processes, Manufacturing Support, Pharmaceutical Manufacturing, Regulatory Compliance, Root Cause Analysis (RCA), Stakeholder Engagement, Stakeholder Relationship ... Management, Standards Compliance, Strategic Thinking, Technical Transfer-Preferred Skills:API ManufacturingJob Posting End Date:08/8/2025 *A job posting is effective until 11:59:59PM on the day BEFORE -the listed job posting end date. Please ensure you apply… more
- Merck & Co. (Rahway, NJ)
- …execution, building housekeeping, and consumable inventory.Provide input for incident root cause analysis, reporting, and action items.Facilitate and drive building ... improvement projects and corrective/preventative action closures.Provide input on process setups.Provide regular feedback to peers to promote a continuous improvement mindset.Collaborate with all building staff to share and align on best practices.Actively… more
- Aequor (Cincinnati, OH)
- …notifying management 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 Monitoring chemical and dry stock inventory Assist with ordering chemicals/materials COMPLIANCE AND QUALITY Basic knowledge and understanding of USP, cGMP, and FDA… more
- Repligen (Waltham, MA)
- …for product manufacture, test and release including deviation support, root cause analysis, customer complaint management, hosting customer/regulatory audits and ... Certificate of Quality generation at an ISO 9001:2015 certified manufacturing site. We are an innovative life sciences company focused on developing and commercializing high-value bioprocessing products, technologies, and solutions critical in the production… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …not 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
- Novo Nordisk Inc. (West Lebanon, IN)
- …requirements Actively participate on cross functional teams to determine the root cause and corrective actions for problems associated with investigations Completes ... accurate and timely assessments associated with change control activities Ensures change control activities for systems are completed in a manner in compliance with FDA, EU and NN regulations Responsible for the verification of new and existing equipment,… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …basic risk mitigation options and advanced troubleshooting to identify root cause and appropriate corrective actions for equipment system problemsHelps ... support the optimization of calibration frequencies through a calibration interval management program including minimally invasive instrumentation tasks which support calibration interval extensionPartner with stakeholders assist in defining user requirements… more
