- Jazz Pharmaceuticals (Redwood City, CA)
- …the execution of issue management processes, assisting and/or leading audit and inspection processes and preparing for governance meetings to achieve compliance, ... inspection readiness, and continuous improvement across the Regulatory and...Affairs, Regulatory Operations and CMC and Labeling organizations in inspection readiness forums. Assist with all inspection … more
- TUV SUD AG (Boston, MA)
- …Bei TUV SUD sind wir in hohem Masse bestrebt, ein wichtiger Teil dieser Entwicklung und des Fortschritts zu sein. Wir sind von Anfang an dabei und begleiten diesen ... Prozess. Wir sorgen fur eine sichere und nachhaltige Zukunft und schaffen Vertrauen in neue Technologien. Wir beraten, wir prufen, wir zertifizieren. Fur die Sicherheit von Menschen und der Gesellschaft fordern wir uns jeden Tag aufs Neue heraus. Wir handeln… more
- Jazz Pharmaceuticals (San Jose, CA)
- …of controls and oversight necessary to achieve compliance, inspection readiness, and continuous improvement. Essential Functions/Responsibilities Provide overall ... GRADS Compliance support in line with the execution of PV and REMS processes and compliance requirements, while ensuring data and scientific integrity practices are followed and consistent with global policies and procedures. Work collaboratively with GRADS… more
- Merck & Co. (Rahway, NJ)
- …integration approaches across MES/MOM, ERP, PLM, IIoT platforms, PLC/SCADA, vision/ inspection systems and robotics. Ensure solutions meet functional, performance, ... (configurable BOMs, dynamic routing, nested work orders, advanced scheduling, in-line inspection and feedback loops). Produce system design inputs, models and… more
- CoxHealth (Lake Spring, MO)
- …assist with supervision of technicians involved in daily cabinet fill and inspection operations. This person is also proficient with wholesaler ordering systems and ... understands inventory management. This person is responsible for monitoring inventory in multiple areas of the pharmacy, as well as monitoring the overstock and shortage related stock. This person is a liaison between pharmacy staff and the pharmacy system… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …In addition, this role will support Compliance initiatives, such as inspection readiness, metrics implementation and review, overall regulatory compliance and ... landscape to stay informed of regulatory trends and developmentsAssist with inspection readiness efforts and program implementation across all sites.Manage and… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …of continuous improvement in benefit-risk evaluation, and participate in inspection readiness activities.Responsibilities:This individual will be the main point of ... a global and regional level as required.Support audit and inspection readiness activities as a subject matter expert. This...individual will be accountable for maintaining a state of inspection readiness and in turn, act as key representer… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …an annual Quality Plan, including quality risk assessments and inspection readiness components for designated programs.Ensure proactive representation of Quality ... a timely manner for earliest resolution, Regulatory Inspections:Facilitates regulatory inspection preparation, management, and follow-up, ensuring thorough management review… more
- Merck & Co. (Rahway, NJ)
- …and operational excellence in the laboratories. Maintains a state of inspection readiness. Performs proactive resourcing planning and risk assessment strategies. ... Communication, Decision Making, Dosage Forms, GMP Compliance, Immunochemistry, Innovation, Inspection Readiness, Learning New Concepts, Manufacturing, Microbiological Analysis, Microbiology,… more
- Merck & Co. (Rahway, NJ)
- …to compliance standards established in 9CFR and enforced by USDA-APHIS-CVB Inspection and Compliance (IC), and Policy, Licensing and Evaluation (PEL).Develop and ... Auditing, GMP Compliance, GMP Operations, Good Manufacturing Practices (GMP), Inspection Readiness, Quality Auditing, Quality Management, Quality Management System… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …global meetings and coordinating dissemination of information and actions Ensure inspection readiness and support audits/ inspection as required Assist Patient ... Safety team projects as required Ensure compliance with role-specific training plans and applicable reference documents Physical Requirements Approximately 0-10% overnight travel. Qualifications A bachelor's degree required (in medical or science-related… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …and ensure appropriate documentation Perform case follow-up activities Participate in inspection readiness and support audits/ inspection as required Ensure ... compliance with role-specific training plans and applicable reference documents Participate in department meetings, internally and globally, as applicable Support mentoring new hires and cross training on case processing associated activities Participating in… more
- Eisai, Inc (Nutley, NJ)
- …of the global Clinical Quality Assurance (CQA) strategy including audit and inspection management, issue management and oversight of the Quality management system. ... (CQA) strategy for the country/region in scope (including audit and inspection management, issue management, and oversight of the quality management system).Conduct… more
- Repligen (Clifton Park, NY)
- …tubing according to work instructions, batch records, and quality standards.Perform inspection of components for defects, damage, or contamination prior to ... and manual dexterity for handling small parts.Ability to perform detailed visual inspection tasks.Ability to stand for extended periods while working in a cleanroom… more
- Eisai, Inc (Baltimore, MD)
- …North America (NA) Clinical Quality Assurance (CQA) strategy including audit and inspection management and oversight of the Quality management system. This role is ... 5+ years of experience in GCP auditing. Substantial experience in inspection management. Substantial experience with US, EU, and international regulatory standards… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …LIMs to align physical quantities of samples in freezers/refrigeratorsPeriodic inspection and consolidation of retainsDocument and perform sample management related ... and guidelinesExperience with Quality Control document reviews and regulatory inspection processesWorking knowledge of Quality systemsExperience in management of… more
- Repligen (Clifton Park, NY)
- …interpret engineering drawings, specifications, and purchase orders.Accurately document inspection results using Microsoft Office and other software.Use precision ... measurement tools like calipers and pin gauges.Operate in an ISO 7 cleanroom while following strict gowning procedures.Support additional quality-related functions as needed.QualificationsWhat You Bring:High School Diploma or equivalent (required); Bachelor's… more
- Merck & Co. (Rahway, NJ)
- …and operational excellence in the laboratories, and for maintaining a state of inspection readiness at all times. The Director should be well engaged with regulatory ... Communication, Cross-Functional Teamwork, Decision Making, Dosage Forms, GMP Compliance, Inspection Readiness, Medical Device Management, Medical Device Manufacturing, Medical… more
- Aequor (Thousand Oaks, CA)
- …for health and control processes. Leads Digital QMS audit & inspection readiness, deviations and change control activities Manage Organizational Change Management ... Experience with risk-based Supplier Quality Management process. Management of Global Inspection and Audit programs Proficient working on multiple projects in a… more
- Merck & Co. (Millsboro, DE)
- …the biologics field or a related area - Quality assurance audits or inspection of vaccine or pharmaceutical manufacturing areas- - Understanding of USDA regulatory ... requirements 9CFR - Required Skills: Analytical Thinking, Batch Record Review, Drug Product Manufacturing, Pharmaceutical Manufacturing, Product Release, Quality Mindset, Regulatory Compliance, USDA Regulations, Vendor AuditsPreferred Skills: Current Employees… more
