- Catalent (San Diego, CA)
- …Summary:Catalent Pharma in San Diego, CA is hiring a Senior Manager of Quality Assurance ( QA ) at our Clinical Supplies facility. As a member ... compliance, and sound fiscal responsibility. The primary responsibilities of the Senior QA Manager include activities related to GMP (Good Manufacturing… more
- Merck & Co. (Durham, NC)
- Job DescriptionOur Quality Assurance group ensures all materials inside our products and the products themselves are manufactured, tested, and distributed in ... product, including biotech culture growth, harvest, lyophilization, product inspection, and quality control laboratories. The Quality Assurance Specialist… more
- Novo Nordisk Inc. (Durham, NC)
- …duties & QA presence & process confirmation on shop floor. Relationships Manager , Quality Assurance . Essential Functions Ensures site compliance with ... Production Records (BPRs), Change Requests (CR's), Deviations & other documentation (in conjunction with LoB) & QA ...ISO standards, corporate & local SOPs Reviews & approves documentation for Quality approval - components/raw material,… more
- Novo Nordisk Inc. (West Lebanon, IN)
- …certify compliance with specifications and procedures Releases product based on Quality Assurance record review and approval by QA Manager Performs ... EMEA or a leading international regulatory agency preferred As applicable, experience with Quality Assurance oversight and support for all phases of Clinical and… more
- Novo Nordisk Inc. (Durham, NC)
- …duties and QA presence & process confirmation on shop floor. Relationships Manager , Quality Assurance . Essential Functions Ensures site compliance with ... ISO standards, corporate & local SOPs Reviews & approves documentation for Quality approval - batch records...degree as appropriate Minimum of one (1) year of QA and/or cGMP related experience required, preferably in the… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …the treatment of multiple myeloma. Legend Biotech is seeking QA Manufacturing Excellence Manager as part of the Quality team based in Raritan, NJ. Role ... Overview The QA Manufacturing Excellence Manager role is an...experience working in an aseptic manufacturing facility, preferably in quality assurance , manufacturing compliance, clinical quality… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …Summary Position is responsible for supports of strategic leadership to manage DSI QA Functional activities and Global QA activities. This position performs ... support tasks Head Global R&D PV QA and Global R&D PV QA Leadership...training, CVs, JDs- Collect, store and maintain all auditable documentation as per DSI Internal control- Support the Head… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …with quality and operations counterparts that include Manufacturing Operations, Quality Assurance , Engineering and Validation, Quality Control and ... treatment of multiple myeloma. Legend Biotech is seeking a QA Warehouse Incoming Raw Material Specialist as part of...is required. Minimum of 4 years of experience in Quality Assurance related to manufacturing is required… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …, Audit Compliance, Quality Management System [QMS] QA , PV/MA Quality ) and in close collaboration with CAPA Manager .), on GxP topics/issues impacting ... and strategic way and through collaboration with other GxP Quality representatives, act as QA point person...and prepare respective management documentation for the QA Head for review at the Quality … more
- Tris Pharma (Monmouth Junction, NJ)
- … Manager , Quality Management Systems (QMS) supports, oversees and manages the Quality Assurance ( QA ) Investigations and Product Quality Complaints ... knowledge or skills needed and/or licenses or certificates preferredCertified Quality Manager , Engineer or AuditorExperience with drug-device combination… more
- Novo Nordisk Inc. (West Lebanon, IN)
- …roles and responsibilities Work closely with Engineering, Automation, Validation, IT, Manufacturing, Quality Assurance and Quality Control, on project teams ... to a better tomorrow for our patients. Ethics and quality are held in the highest regard, and a...for selected candidate. Relationships Reports to: Sr. Operational Excellence Manager plus additional interfacing with Manager of… more
- Novo Nordisk Inc. (Boulder, CO)
- …& other stakeholders, & presentation in steering groups Support local Quality Assurance unit activities Business Process Improvements: Manage activities ... to support analytical and process development, the CMC team works alongside Quality , Regulatory, Technical Operations and RNAi Early Development professionals at our… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …candidate have experience working in an aseptic manufacturing facility, preferably in quality assurance , manufacturing compliance, clinical quality , or cell ... of an immunotherapy in the treatment of multiple myeloma. Legend Biotech is seeking Quality Systems Lead role as part of the Quality Operations team based… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …Non-GxP computer systems implementations in partnership with Global DX, and QA -CSV/eCompliance team members to ensure compliant, efficient and timely completion of ... for CSV projects. Work within a risk-based framework (Computer Software Assurance (CSA)) that is compliant with global regulatory expectations and business… more
- Novo Nordisk Inc. (West Lebanon, IN)
- …support, including Service delivery and Incident response) IT Infrastructure SME for Quality assurance / GMP and Validation: Maintain qualified state of ... to a better tomorrow for our patients. Ethics and quality are held in the highest regard, and a...IT Operations Direct Reports: None Essential Functions IT Infrastructure Manager , covering GxP and non-GXP systems: Drive and maintain… more
- Exela Pharma Sciences, LLC (Lenoir, NC)
- …support of commercialization. Serve as a technical resource to improve product quality , reliability, and process capability. Support manufacturing to satisfy the ... quality and process validation requirements for existing products. Participate...and EU requirementsCollaborate with peers and stakeholders to in QA and Manufacturing to identify opportunities for process improvementFacilitate… more
- Catalent (Manassas, VA)
- … System documentation . Communicate any deviations to management. Assist the Quality Assurance team with special projects as required. Comply with SQF, ... based positionThe Role:Support the creation and maintenance of all documentation related to the Quality System utilizing...and track result data; Report any deviations to the Quality Systems and Regulatory Manager in complete,… more
- Novo Nordisk Inc. (Boulder, CO)
- …Chemical Development, Analytical Services, Engineering, Facilities, EH&S, Program Management and Quality Assurance . The Technical Team Lead, API Manufacturing ... to support analytical and process development, the CMC team works alongside Quality , Regulatory, Technical Operations and RNAi Early Development professionals at our… more
- AdventHealth (Maitland, FL)
- …coding, CDI review, working on Electronic Medical Record tools, Communication protocols, and Quality Assurance ( QA ) and compliance programs to effectively ... **The role you'll contribute:** The Population Health Services Organization (PHSO) Senior Manager of Clinical Documentation Integrity (CDI) will be responsible… more
- Hawaiian Airlines (Honolulu, HI)
- …air carrier or military equivalent in the field of aircraft Technical Publications, Quality Assurance , auditing, or engineering. * Strong working knowledge of ... documentation standards and processes, manages the technical documentation vendors, and oversees product quality control,...and SmartSheet. * ** Experience with Airbus Flight Ops Documentation Manager (FODM). * * * *… more
