- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …for Daiichi Sankyo by various contractors meets Global DX Computer System Validation requirements, global regulatory compliance, and global Quality expectations. ... or More Years First-hand knowledge of GAMP5, GxP and Non-GxP computer system validation and qualification and Computer Software Assurance (CSA), SDLC related to… more
- Exela Pharma Sciences, LLC (Lenoir, NC)
- …, reliability, and process capability. Support manufacturing to satisfy the quality and process validation requirements for existing products. Participate ... audienceAt least 8 years' experience in the biotech/pharmaceutical industry in validation , quality management, process controls, and continuous improvement in… more
- 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 ... and communications with client QA counterparts. Site Recall/ Quality alert program, Facility/equipment/process/analysis method/cleaning validation and… more
- Novo Nordisk Inc. (Durham, NC)
- …duties & QA presence & process confirmation on shop floor. Relationships Manager , Quality Assurance . Essential Functions Ensures site compliance with ... shop floor. Handles release of raw materials & provides quality oversight, review & approval of validation ...components/raw material, batch records, change control requests, deviations & validation documents Performs QA presence & process… 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 ... degree as appropriate Minimum of one (1) year of QA and/or cGMP related experience required, preferably in the...device industry General knowledge of Batch Review Processes (BRP), validation processes and Quality Management Systems (QMS)… 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
- Catalent (St. Petersburg, FL)
- … QA Product Manager is responsible for providing Leadership and Quality Assurance Management support within at Catalent's St. Petersburg site. The ... Product Manager is responsible for the overall Quality Assurance review and approval of all...and/or equivalent combination of education and experience in the QA pharmaceutical industries. Prior experience working with validation… 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 ... and GMP for all NNUSBPI products. This position has QA signature authority on the review of individual batch...leading international regulatory agency preferred As applicable, experience with Quality Assurance oversight and support for all… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …setting with quality and operations counterparts that include Manufacturing Operations, Quality Assurance , Engineering and Validation , Quality ... 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
- Aequor (Seattle, WA)
- …of manufacturing quality (manufacturing, packaging, facilities, critical systems, validation , etc.). Must complete tasks independently, notify manager of ... great communication - Experience working cross-functionally Position Summary: The Quality Assurance Document Control (QADC) Associate Specialist supports… more
- Novo Nordisk Inc. (West Lebanon, IN)
- …team to identify roles and responsibilities Work closely with Engineering, Automation, Validation , IT, Manufacturing, Quality Assurance and Quality ... 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. (West Lebanon, IN)
- …user/desktop support, including Service delivery and Incident response) IT Infrastructure SME for Quality assurance / GMP and Validation : Maintain qualified ... 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
- Bristol Myers Squibb (Bothell, WA)
- …personal lives. Read more: careers.bms.com/working-with-us . **Position Summary** The Senior Manager , Validation , Engineering and Technology is responsible for ... Validation , Engineering & Technology (VET) team. The Senior Manager will also oversee ad hoc teams performing VET...Work will heavily involve the use and management of validation document control and quality system software… more
- Regeneron Pharmaceuticals (East Greenbush, NY)
- … Fill Finish team is hiring an Associate Manager ! As the Associate Manager QA Validation you will validate/qualify equipment, systems, and processes ... implements required processes, as needed, to meet expectations regarding Quality . + Participates in regulatory and customer activities. +...of years of experience for each level: + Associate Manager QA Validation : 6+ years… more
- Regeneron Pharmaceuticals (East Greenbush, NY)
- … QA Validation department at Regeneron is adding to their team! The ** Manager QA Validation - External Partners** leads a department responsible for ... the qualification of the equipment, systems, and processes validation for our CMO and partner groups in accordance with regulatory requirements and support, follow… more
- Glenmark Pharmaceuticals Inc., USA (Monroe, NC)
- Manager , QA Validation Department: ...analysis process and build improved efficiency. + Manage the validation system from a Quality Assurance ... leading integrated research-based pharmaceutical company. POSITION SUMMARY : The Manager , QA Validation is responsible...Experience : + A 6-10 years of experience in Quality Assurance or Design Assurance … more
- Regeneron Pharmaceuticals (East Greenbush, NY)
- The QA Validation department at Regeneron is adding to their team! The ** Manager for QA Validation within our Fill Finish area** would lead the ... Shifts Available: 2nd Shift, Monday-Friday, 2pm-10:30pm The day to day of a Manager for QA Validation could include, but are not limited to, the following:… more
- Cook Medical (Pittsburgh, PA)
- …especially the Computer System Applications, Information Technology, and Quality Assurance departments, to establish the philosophy for validation approaches ... integrity, we invite you to apply. The Computer System Validation Manager at Cook MyoSite, Inc. manages...IQs, OQs, PQs, VSs, etc.) as needed.* Work with Quality Assurance to ensure alignment for an… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …for Daiichi Sankyo by various contractors meets Global DX Computer System Validation requirements, global regulatory compliance, and global Quality expectations. ... or More Years First-hand knowledge of GAMP5, GxP and Non-GxP computer system validation and qualification and Computer Software Assurance (CSA), SDLC related to… more
- PCI Pharma Services (Bedford, NH)
- … department personnel and cross-functionally with MTS, Manufacturing, Engineering, QC, Quality Assurance , and project management to achieve all project ... future of PCI. **JOB SUMMARY** Reporting to the Senior Manager process Validation , the Process Validation...clients and multiple departments including Operations, MTS, Engineering, Facilities, Quality Control and Quality Assurance .… more
