- Novo Nordisk Inc. (Durham, NC)
- …our employees to embark on life-changing careers, and the opportunity to help improve the quality of life for millions of people around the world. In NC, we operate ... help us make what matters. The Position Plan, manage & perform laboratory validation activities. Routine review of laboratory validation procedures & completed … more
- Novo Nordisk Inc. (Durham, NC)
- …for Quality approval - components/raw material, batch records, change control requests, deviations & validation documents Performs QA presence & ... shop floor. Handles release of raw materials & provides quality oversight, review & approval of validation ...provides quality oversight, review & approval of validation activities associated with minor changes to existing systems.… more
- Novo Nordisk Inc. (Durham, NC)
- …our employees to embark on life-changing careers, and the opportunity to help improve the quality of life for millions of people around the world. In NC, we operate ... problems solving Understand & execute GMP & compliance protocols for instrument validation Executes work according to schedule & department plan Evaluates instrument… more
- Novo Nordisk Inc. (West Lebanon, IN)
- …realize your potential? The Position This position has primary responsibility to support Quality Control (QC) operations in the microbiology or analytical ... to cGMPs, established manufacturing practices and procedures, and compliance with quality regulations and guidelines. This position carries out routine QC testing… more
- Novo Nordisk Inc. (West Lebanon, IN)
- …of NNUSBPI facilities as a lead auditor Works closely with Manufacturing and Quality Control to resolve open issues resulting from record reviews, internal ... to a better tomorrow for our patients. Ethics and quality are held in the highest regard, and a...Possess signature authority for deviation closure Reviews and approves Validation Documentation Reviews and assesses Corrective and Preventive Action… more
- Novo Nordisk Inc. (West Lebanon, IN)
- …certify compliance with specifications and procedures Works closely with Manufacturing and Quality Control to resolve open issues resulting from record reviews, ... Review and assess Corrective and Preventive Actions Reviews and approves validation documentation Reviews and assesses deviations; includes tracking, follow-up and… more
- Merck & Co. (Rahway, NJ)
- …stakeholder expectations; facilitation of cross-functional decisions.3. Defines trial-level requirements for quality data collection and validation at the trial ... data validation plan (including project and protocol specific data validation elements).4. Manages trial-level data quality and completion of database… more
- Exela Pharma Sciences, LLC (Lenoir, NC)
- …opportunities Review relevant Investigations, Change Control , and CAPA(s)Work with Area Management to drive Quality Culture Providing Quality ... Quality presence in warehouse, dispensing, and manufacturing areasSupport validation and qualification activities Perform Spot-Check Data Reviews Change … more
- Merck & Co. (Rahway, NJ)
- …ensure compliance with regulatory requirements.Execute and develop appropriate system validation , change control , and testing documentation.Maintain familiarity ... of validation activities and all other associated computer system quality functions. Applies general knowledge of company business developed through education or… more
- Merck & Co. (Durham, NC)
- …or review and approval of system commissioning and qualification documents, change control , automation incidents, Quality Notifications (QNs), and other key ... embrace an empowered team culture including significant interaction with manufacturing, quality , IT, and engineering groups. - The Senior Specialist for… more
- Merck & Co. (Rahway, NJ)
- …support several automation systems across the Rahway Site including ABB Distributed Control Systems, environmental control systems and equipment utility metering ... Rahway Powerhouse/Utilities/Environmental Operations space, interfacing with key partners and area leadership to ensure delivery of business objectives, including… more
- Merck & Co. (Durham, NC)
- …manufacturing systems, in partnership with maintenance, technical operations, operations, validation , and quality personnel.Performs routine system monitoring ... is a member of the Automation team responsible for the support of process control systems used in manufacturing operations located in Durham, NC.- We use a variety… more
- Novo Nordisk Inc. (West Lebanon, IN)
- …in facilities such processing, engineering, design, project coordination, start-up and validation of GMP and non-GMP utilities and facilities areas and systems. ... Essential Functions Provides support to a designated manufacturing operations area including the following activities Equipment and system troubleshooting to… more
- Novo Nordisk Inc. (West Lebanon, IN)
- …to job function, and regulatory requirements for the operation of the area Support evaluation, specification, installation, and validation of new manufacturing ... together to contribute to a better tomorrow for our patients. Ethics and quality are held in the highest regard, and a patient-focused mindset guides everything… more
- Sutter Health (Berkeley, CA)
- …enabling the accurate, timely, and efficient completion of instrument maintenance, quality control , non-conforming event management, and records management.Job ... oversight of equipment maintenance. The Individual is responsible for the validation , development, and/or implementation of new procedures, policies, equipment, and… more
- Novo Nordisk (Durham, NC)
- …our employees to embark on life-changing careers, and the opportunity to help improve the quality of life for millions of people around the world. In NC, we operate ... help us make what matters. The Position Plan, manage & perform laboratory validation activities. Routine review of laboratory validation procedures & completed … more
- Bristol Myers Squibb (Bothell, WA)
- …of Materials Management, Manufacturing, Patient Services, Scheduling, Quality Assurance, Quality Control , and Validation + Investigate and resolve ... as a subject matter expert for aseptic and environmental control programs + Support quality record processing...and occasionally leads one or more projects within the validation area and contributes to more complex… more
- Hovione (East Windsor, NJ)
- … methodologies among Digital (Automation/IT), Engineering, Maintenance, Production Areas and Quality Control , when applicable, to benefit systems compliance - ... of Quality Systems key activities - Prepare/review Quality Systems methodologies related to the area ... Control /close/approve deviations, CAPA, improvement plans, and change control related to Qualification and Validation of… more
- ICU Medical (Dublin, OH)
- …and revised validation guidelines, specifications and policies . Interact with Quality , Engineering, Manufacturing, Packaging, IT, and business area users as ... *Position Summary:*// The Validation Engineer II is responsible for process knowledge... section assigned to: . Equipment . Automated process control systems/Computerized systems . Process & Cleaning . Terminal… more
- Bristol Myers Squibb (Bothell, WA)
- …long term strategy of VET. Work will heavily involve the use and management of validation document control and quality system software and applications (eg ... Senior Manager oversees the Right to Operate, Operational Excellence and Ongoing Monitoring area within the Validation , Engineering & Technology (VET) team. The… more
