- Aequor (Libertyville, IL)
- …focus of the MSAT Technical Writer is to investigate and write root cause analyses for non-conformance events during the manufacturing of cell therapy vector.. The ... modes Learns complex cell biology concepts & applies them to root cause investigations Works independently and with Process Engineer(s) to understand different… more
- Novo Nordisk Inc. (West Lebanon, IN)
- …information associated with operational deviations. Will lead and facilitate root cause analysis investigations with site personnel and determine the associated ... and Quality teams Lead cross-functional investigation teams to identify root cause , evaluate technical impact, and provide recommendations on batch disposition… more
- Merck & Co. (Rahway, NJ)
- …local country operations & local CQM team, identifies local trends, performs root- cause -analysis (if necessary), develops local action plan (incl. sharing of results ... with local CCQM, local country operations and/or headquarters, performs root- cause -analysis for audit observations/inspection findings, manages and tracks the… more
- Insmed Incorporated (Bridgewater, NJ)
- …and Third-party AuditsComplex deviations are investigated with thorough root cause analysis, documented with corrective actions for prevention of reoccurrence. ... will also be considered.Preferred ASQ CQE certification and/or Root Cause Analysis CertificationExperience with product quality complaints in regulated… more
- Novo Nordisk Inc. (West Lebanon, IN)
- …performance, advanced interview techniques, standardized data collection methods, branching cause maps, and other methods Maintain expertise in deviation ... a pre-deviation state Lead cross-functional investigation teams to identify root cause , evaluate technical impact, and provide recommendations to management on batch… more
- Exela Pharma Sciences, LLC (Lenoir, NC)
- …data from various sources across the organization in order to lead and perform Root Cause Analysis to determine the most likely cause of the deviation and ... appropriate and timely determination of scope, potential product impact, root cause , and corrective and/or preventive actionsAuthor and manage several investigations… more
- Aequor (Thousand Oaks, CA)
- …Manages Change Control Records. Owns and Manages Deviations, and Lead Root Cause Analysis. Develops, writes, edits, and formats materials such as Standard Operating ... control records Own and manage minor and major deviation records and lead root cause analysis sessions Own and manage CAPA and CAPA EV records, ensuring that they… more
- Catalent (St. Petersburg, FL)
- …with others on site events to verify scope of investigations, assure root cause analysis and batch impact assessment are adequate, and recommend corrective actions ... pharmaceutical operation.Prior experience working with investigation writing, including root cause analysis and report writing a must.Prior experience with preparing… more
- Merck & Co. (North Wales, PA)
- …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) with a minimum of 7 years… more
- Merck & Co. (Rahway, NJ)
- …of managing complex issues, solution-oriented approach.Ability to perform root cause analysis and implement preventative and corrective-action. Behavioral Competency ... Expectations: Effective time management, organizational and interpersonal skills, conflict-managementAble to work with other experienced research professions to develop skills across multiple protocols, sites and therapy areas.High sense of accountability /… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …management.Support GCO Quality by Design, risk management, issue management, and root cause analyses.As needed, may be involved in due diligence activities during ... the vendor selection process.Close partnership with clinical quality management, SVO and other compliance functions within and outside of GDO, global process owners, and other support functions, to ensure a community of practice centered on Quality by Design,… more
- Merck & Co. (Durham, NC)
- …and people) to best understand and resolve it at root cause .--Maintain alignment with internal Technical personnel regarding validation practices for products, ... processes and equipment.Partner with Operations, Quality, and Automation functional areas on validation study implementation. Position Qualifications: Education Minimum Requirement: Bachelor of Science Degree in Engineering or Life Sciences with a minimum of… more
- Aequor (Athens, GA)
- …organizational skills with ability to multi-task and prioritize -Experience in root cause analysis tools -Ability to understand and comply with Quality Assurance and ... regulatory requirements (9CFR, Outlines of Production,etc.) -Computer skills in Microsoft Office applications and the ability to quickly and easily learn new applications Associates degree 0- 2 years of relevant industry experience required; Bachelors degree… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …Offer technical expertise and guidance to investigation teams in root cause analysis methodologies and Corrective and Preventive Action (CAPA) implementation. ... within a GMP-regulated environment. Strong understanding of GMP regulations, root cause analysis methodologies, and CAPA processes. Proven leadership and team… more
- BioAgilytix (Durham, NC)
- …Employee Relations (ER) data to determine trends, themes, and root cause to provide insights, training, and recommendations.Assist with ideation of employee ... relations content, project work and other duties.Manage the Annual Employee Engagement Survey Process as well as the review of results, and action planning process. Proven ability to analyze current and emerging trends (best practices) and use various survey… more
- Catalent (Manassas, VA)
- …and stability metrics, and liaise with related departments to identify root cause . Work closely with Production Supervisors to adequately support all planning ... activities in a timely manner; Track Production Actual to Plan; Enter and manage production using planning tools such as Excel, PowerPoint and the ERP System. Create and modify the Master Schedule and shift specific short-term production schedules; Participate… more
- Aequor (Davie, FL)
- …with minimal supervision able to write protocol deviations and identify root cause and corrective actions Master's or Ph.D. in Science, Engineering or pharmacy ... required (Chemical, biomedical or Mechanical preferred) 2-5 years of experience within pharmaceutical or related manufacturing facility Prefer previous experience in a manufacturing environment within pharmaceutical. POSITION SUMMARY Under general supervision,… 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 Procedures Required to wear personal protective equipment including safety glasses, earplugs, gloves, hard hats, safety harnesses, etc.- Position requires clean room gowning during performance of job duties Actively supports safety initiatives,… more
- Merck & Co. (Durham, NC)
- …FOCUS:Responds to standard requests from clients and/or customersIMPACT:Errors on the job may cause time delays and impact the work of others in own work group ... or potentially impact product dispositionInfluence and Decision Making:Represents Quality on the shop floor to influence cGMP compliance and ensure product quality.Explains information and persuades others in straightforward situationsMakes decisions within… more
- Merck & Co. (Durham, NC)
- …ultrasound, IR, etc.Experience with formal problem-solving techniques, such as root cause analysis (RCA), failure mode effects analysis (FMEA), and/or Lean Six ... Sigma tools.Working knowledge of current Good Manufacturing Practices(cGMP) experience in a sterile, bulk or finished pharmaceutical environmentDemonstrated experience of interacting with site, divisional or regulatory auditsGreen Belt/Black Belt… more
