- Aequor (Libertyville, IL)
- …to understand different failure modes Works with GMP Quality Systems to deliver completed Root Cause Analysis investigation reports Education: BS in Bio/Chem ... summarizes characterization data to write root cause investigations Utilizes root cause analysis tools such as fishbone, 6Ms, Five Whys, to identify … more
- Novo Nordisk Inc. (West Lebanon, IN)
- …necessary data and information associated with operational deviations. Will lead and facilitate root cause analysis investigations with site personnel and ... trends and identify opportunities for operational improvements Coach and drive root cause analysis (RCA) conducts personnel interviews to determine the … more
- Merck & Co. (Rahway, NJ)
- …with local country operations & local CQM team, identifies local trends, performs root - cause - analysis (if necessary), develops local action plan (incl. ... cooperation with local CCQM, local country operations and/or headquarters, performs root - cause - analysis for audit observations/inspection findings, manages… more
- Novo Nordisk Inc. (West Lebanon, IN)
- …in the use of problem solving tools: A3, 5-WHY, Fish-bone diagram, Is and Is-Not, Root Cause Analysis , Human Error Reduction Demonstrated ability of meeting ... decisions based on the written investigation report Experienced in troubleshooting, investigation, and root - cause analysis in a cGMP environment Ability to… more
- Aequor (Thousand Oaks, CA)
- …Details: Owns and Manages Change Control Records. Owns and Manages Deviations, and Lead Root Cause Analysis . Develops, writes, edits, and formats materials ... change control records Own and manage minor and major deviation records and lead root cause analysis sessions Own and manage CAPA and CAPA EV records,… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …Provide Technical Oversight: Offer technical expertise and guidance to investigation teams in root cause analysis methodologies and Corrective and Preventive ... investigations management within a GMP-regulated environment. Strong understanding of GMP regulations, root cause analysis methodologies, and CAPA processes.… more
- Exela Pharma Sciences, LLC (Lenoir, NC)
- …to gather data from various sources across the organization in order to lead and perform Root Cause Analysis to determine the most likely cause of ... to ensure appropriate and timely determination of scope, potential product impact, root cause , and corrective and/or preventive actionsAuthor and manage several… more
- Catalent (St. Petersburg, FL)
- …and work closely with others on site events to verify scope of investigations, assure root cause analysis and batch impact assessment are adequate, and ... and/or manufacturing pharmaceutical operation.Prior experience working with investigation writing, including root cause analysis and report writing a… more
- Merck & Co. (North Wales, PA)
- …principles is desirable.Lean Six Sigma Principles and tools such as: DOEs, Root cause analysis and/or Problem-solving methods are desired.Experience ... in the use of root cause analysis and applied statistical techniques.Qualifications: A bachelor's degree in (Science or Engineering or associated fields)… more
- Exela Pharma Sciences, LLC (Lenoir, NC)
- …performance data to optimize maintenance activity effectiveness and maximize equipment uptime.Implement root cause analysis processes of equipment failures ... policies and procedures as required in a maintenance environment.Oversee evaluation of root cause of significant equipment breakdowns and develop countermeasures… more
