- Novo Nordisk Inc. (Boulder, CO)
- …timely fashion and in a manner which meets their expectations Acts in role of lead Quality Assurance for NN Boulder Change Control process, including review ... processes at NN Boulder, specifically in the role of Quality Assurance ( QA ) subject matter...support staff Demonstrate leadership skills via acting as project lead on cross-functional projects in the development and/or implementation… more
- Novo Nordisk Inc. (West Lebanon, IN)
- …compliance with specifications and procedures Releases product based on Quality Assurance record review and approval by QA Manager Performs regular internal ... audits of NNUSBPI facilities as a lead auditor Works closely with Manufacturing and ...leading international regulatory agency preferred As applicable, experience with Quality Assurance oversight and support for all… more
- Catalent (Philadelphia, PA)
- …PA is hiring a QA Supervisor. The QA Supervisor will p rovide Quality Assurance support for the Quality Inspectors on the production floor, incoming ... QA Supervisor Position Summary Catalent Pharma Solutions in...material quality , and/or distribution quality , including quality oversight for material management… more
- Catalent (Philadelphia, PA)
- Quality Assurance Document Control Supervisor Position Summary Catalent Pharma Solutions in Philadelphia, PA is hiring a Quality Assurance Document ... committed to a Patient First culture through excellence in quality and compliance, and to the safety of every...SOPs related to batch record documentation and release.Act as lead investigator for all Problem Reports regarding batch record… more
- Insmed Incorporated (Bridgewater, NJ)
- …knowledge of cGMPs and pharmaceutical manufacturing, Quality Control and Quality Assurance .Commercial drug manufacturing site QA head experience ... follow relevant regulatory GMPs and global company policies & proceduresLead overall management of Quality Assurance programs to support the QC lab and to ensure… more
- Catalent (San Diego, CA)
- Job Title: Quality Assurance Associate, Analytical City: San Diego State : CA JOB DESCRIPTION:Review of analytical release and stability data, involving review ... and manufacturing equipment.Point person for safety complaints and improvements in the Quality Assurance Department using the Intelex software for logging… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- … team based in Raritan, NJ. Role Overview The QA Investigations Lead has the responsibilities for providing quality oversight over the production of ... treatment of multiple myeloma. Legend Biotech is seeking a QA Investigations Lead (2nd or 3rd shift)...experience working in an aseptic manufacturing facility, preferably in quality assurance , manufacturing compliance, clinical quality… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …the candidate hasexperience working in an aseptic manufacturing facility, preferably in quality assurance ,manufacturing compliance, clinical quality , or cell ... QA Shop Floor Supervisor as part of the Quality team based in Raritan, NJ. Role Overview The...supervising employees is preferred. Ability to work with and lead others in a team environment. Demonstrated ability to… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …Supervise a team of QA Investigations Leads. Provide guidance to the Quality Leaders about handling the various nonconformances. Lead the daily touch point ... must have experience working in an aseptic manufacturing facility, preferably in quality assurance , manufacturing compliance, clinical quality , or cell… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …to ensure that shared point data is current and accurate- In collaboration with the Lead Global QA Strategy and Operations (RDPVMA QA ), Collate and produce ... Summary Position is responsible for supports of strategic leadership to manage DSI QA Functional activities and Global QA activities. This position performs… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …and label proofs.Manages the packaging Batch Record review and approval process with Quality Assurance and other CSO personnel.Works closely with Quality ... Trial Master Files (TMF) with CSO-related documentsSupports the CSO Project Mgmt Lead in executing additional operational and logistical duties as discussed and… more
- Merck & Co. (Durham, NC)
- …in state of control based on Sterility Assurance requirements ensuring an integral process.- Lead a Quality team to provide QA support to assigned areas ... Job DescriptionOur Teknika Quality Assurance group ensures every single material inside our products is manufactured, tested, and distributed in alignment with… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …The Technology Management (mAb, Drug Substance, Drug Product, or New Modality) Lead is responsible for the management of technology transfer of the manufacturing ... supports Supply Chain Management with technical issues post first CPV.Responsibilities- Lead and coordinate the Site-Launch activities and associated teams for… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …expertise and solutions to CSV questions and issues.Responsibilities- Provide Validation Lead support for Daiichi Sankyo GxP and Non-GxP computer systems ... implementations in partnership with Global DX, and QA -CSV/eCompliance team members to ensure compliant, efficient and timely completion of global DX GxP and Non-GxP… more
- EY (Hartford, CT)
- …build an exceptional experience for yourself, and a better working world for all. Quality Assurance Lead , Financial Services Office (Manager) (Multiple ... field and 5 years of progressive, post-baccalaureate work experience in software quality assurance and testing. Alternatively, will accept a Master's degree… more
- Tris Pharma (Monmouth Junction, NJ)
- …Summary:The Manager, Quality Management Systems (QMS) supports, oversees and manages the Quality Assurance ( QA ) Investigations and Product Quality ... Improvements (CPIs)Works directly and cross functionally throughout company (ie, QA Operations, Quality Control (QC), Manufacturing, Operations, Technical… 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...other local SMEs in IT/OT, System Managers, and IT QA Maintain IT services and operations according to service… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …& Leadership Has primary accountability for operational study level time, cost and quality deliverables. Lead the development of the clinical study plan ... Oversee the site qualification process.Monitor clinical trial performance and quality metrics and share with study team, Operations Program...of the operations lead of study team lead . Coordinate and liaise with Daiichi Sankyo QA… more
- Merck & Co. (Durham, NC)
- …data. This role requires close collaboration with various teams including Production, Quality Assurance , Validation and Facilities, as well as external ... improvements, report writing, involvement in interdepartmental committees and projectsInitiate and lead Change Requests utilizing IPIParticipate in Quality Risk… more
- Insmed Incorporated (Bridgewater, NJ)
- …substance sections of regulatory filings and dossiers.Sound awareness of Regulatory, Quality Assurance , and cGMP requirementsHigh energy, innovative "can do" ... for being the Technical Operations liaison to the Insmed research team for lead optimization and early development programs. This position will be the dynamic… more
