- Arthrex (Ave Maria, FL)
- …with all quality related support for improving and maintaining the Arthrex global Quality Management System (QMS) to ensure compliance to FDA QSR, ISO ... orthopedics. Arthrex is actively searching for an Engineer I Quality Systems and Regulatory Compliance for our...Agile, SAP or similar inventory software as well as CAPA , NCR, Audit or Complaint Management software.Reasoning… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …will provide strategic direction and leadership for the investigations management system . Working closely with the Quality Senior Manager, this position will ... the Quality Associate Director to co-lead the deviation investigations management system . Ensure alignment with GMP regulations and organizational objectives… more
- Novo Nordisk Inc. (West Lebanon, IN)
- …for the quality and oversight of the deviation investigation and CAPA (corrective actions and preventive actions) management processes. The Deviation Leader ... to a better tomorrow for our patients. Ethics and quality are held in the highest regard, and a...in the pharmaceutical/biotech industry. Experience with deviation or investigation management systems Ability to put complex thoughts… more
- Connexion Systems & Engineering (Danvers, MA)
- … quality products too. Skills/Qualifications (mandatory on resume): Supplier Management Process Improvement Product Quality Six Sigma Desired ... Job Summary Responsible for qualifying, managing suppliers, perform audit, CAPA review, scorecards, FAI review /approvals and lead APCD supplier quality issues.… more
- Sunrise Systems Inc (Summit, NJ)
- …Ability to utilize electronic Quality systems such as eQRMs (Enterprise Quality and Regulatory Management system ) or Infinity. Hands on experience ... results, authoring investigation reports, identifying corrective and preventive actions ( CAPA ), and troubleshooting complex problems. The successful incumbent must… more
- Aequor (Thousand Oaks, CA)
- …accuracy, consistency and quality . Maintain data accuracy and perform data analysis for Management reviews of the quality system on a periodic basis. ... intended. Maintain data accuracy and perform data analysis for Management reviews of the quality system...processing, database and spreadsheet application skills and experience in Quality Management Software systems (eg… more
- Novo Nordisk Inc. (West Lebanon, IN)
- …and Abilities: Strong working knowledge of facility related systems including Clean Water Systems , Clean Steam System , HVAC Systems , and Compressed Gas ... to a better tomorrow for our patients. Ethics and quality are held in the highest regard, and a...projects to ensure proper working order and compliance of systems with cGMP's. Assists with preparation of yearly Facilities… more
- Eisai, Inc (Nutley, NJ)
- … system audits for review of SDLC and data integrity controls. Review CAPA and verification of CAPAs of system audits. Support health authority ... want to hear from you. Essential Functions QA approver for internal computer system validation efforts. Act as liaison to the business for guidance and consultancy… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …within a cGMP manufacturing environment Advanced proficiency in the use of ERP systems , Warehouse Management Systems , and analytics Ability to promote ... be responsible for the ongoing site ramp-up, daily operational management , as well as continuous improvement of cGMP Warehouse...Support the treatment and on time closure of deviations, Quality investigations and CAPA 's related to operational… more
- Novo Nordisk Inc. (WA)
- …and mitigation planning for assigned clinical trial sites, leveraging Risk Based Quality Management (RBQM) principles and tools; executes activities relevant to ... evolve, so does our challenge to find better and more innovative ways to improve their quality of life. We're changing lives for a living. Are you ready to make a… more
- Creative Financial Staffing (Union, MI)
- …customer interaction regarding quality -related matters. The role will oversee the quality management system , ensuring consistent production quality , ... response to voluntary standards, regulatory changes, and customer demands. Serve as the management representative for all quality system matters. Conduct… more
- CIRCOR International, Inc (Corona, CA)
- …technical publications, component maintenance manuals, purchase orders, etc.), and quality system management .Principal ActivitiesInterface with customer ... mode and effects analysis, 8-D, Pareto, fault tree analysis, and Ishikawa diagrams.Aerospace Quality Management Systems : ISO 9001, AS9100, AS9110, FAR 21,… more
- Sunrise Systems Inc (Bothell, WA)
- …(8) or more years of relevant work experience in pharmaceutical quality operations, quality assurance, quality systems , and/or IT compliance role with at ... AND SCOPE OF POSITION: This position reports into the Quality Assurance department and is responsible for assisting with...and is responsible for assisting with the implementation and management of Client's GMP Data Governance and Data Integrity… more
- Sunrise System Inc (Warren, NJ)
- …grow and develop. GMP, GLP experience Sample coordinator/ management experience Quality control, compliance systems experience (Dev/ CAPA ) Additional Job ... Requirements: Position Handles Hazardous Material Additional Job Requirements: Position Handles Hazardous Materials more
- Merck & Co. (Rahway, NJ)
- …equipment/ system change controls, execute periodic reviews and support Quality Management System (QMS) activities.-Provide technical expertise, ... systems (administration and execution) as well as Computerized Maintenance and Management Systems (CMMS). Knowledge and experience of sterile drug product… more
- US Tech Solutions, Inc. (Austin, TX)
- …medical devices and combination products. . Knowledge of FDA requirements for Quality Systems , pharmaceutical products, and Medical Device Skills: . Tech ... written/verbal communication and organizational skills. . Knowledge and application of computer systems for word processing and complaint management . . Ability… more
- Eisai, Inc (Raleigh, NC)
- …profile, we want to hear from you. Essential Functions Overall leadership of the Product Quality QC Biologics team. US staff are both remote and based out of the ... investigations into lab related deviations, discrepancies, and ensure appropriate CAPA is assigned to remediate recurrence.Responsible for talent development within… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …be responsible in handling day-to-day activities inclusive of execution, protocol management , vendor management , issues, deviations, corrections and remediation ... efforts for facility, equipment, systems and processes in support of personalized cell therapy...contractors/vendors to complete tasks Supports and/or owns technical and quality investigations, CAPAs and corrections Develops and performs any… more
- CIRCOR International, Inc (Tampa, FL)
- …process flow charts/diagrams and process failure mode effects analyses reportsOn-going management of Quality systems , processes, and procedures.Manage ... Specialist II ORGANIZATIONAL STRUCTUREBUSINESS: Leslie Controls, IncLOCATION: TampaDIRECT REPORTING: Quality Systems ManagerPOSITION DETAILSPosition SummaryThe Calibration Specialist… more
- Arthrex (Ave Maria, FL)
- …Facility processes; Function as lead auditor and/or subject matter expert for quality management system audits of Arthrex's sterilization service ... Inc (AMI) Sterilization Facility's quality assurance program in accordance with Quality Systems Requirements. Join our talented team at a global medical… more
