- 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
- 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
- Novo Nordisk Inc. (West Lebanon, IN)
- …walk-through audits of NNUSBPI Manufacturing facilities Releases product based on Quality Assurance record review and approval by Manager , Quality ... and GMP for all NNUSBPI products. This position has QA signature authority on the review of individual batch...pharmaceutical or biotechnology company with one (1) year direct Quality Assurance experience Knowledge, Skills, and Abilities:… 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
- Catalent (St. Petersburg, FL)
- Manager , QA (Product Development)Position SummaryThe Quality Assurance Department is responsible for providing Leadership and Quality Assurance ... and could include all or some aspects of the Quality function.The Product Development QA Manager... Manager is responsible for the overall Quality Assurance review and approval of all… 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
- 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
- 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
- Catalent (St. Petersburg, FL)
- …employee. Compliance Manager is responsible for providing Leadership and Quality Assurance Management support within Catalent's St. Petersburg site. The ... Control, Equipment/Facilities, Change Control, etc. The focus of each QA Manager may be dependent upon the...and could include all or some aspects of the Quality function.The RoleEnforce Computerized System Validation (CSV)… more
- Merck & Co. (Durham, NC)
- Job DescriptionOur Quality Assurance group ensures every single material inside our products is manufactured, processed, tested, packaged, stored and distributed ... P1 position on the 2/2/3 schedule. The Shop Floor Quality Assurance Associate is responsible for all...pushing and pullingAbility to travel WORKING RELATIONSHIPS: Reports to Quality Manager Interacts with employees within own… more
- BioAgilytix (Durham, NC)
- …a strong working relationship and open communications with all departments, including Quality Control, Quality Assurance and Sample ManagementMaintain ... all phases of our client services. As a Project Manager I, you will be the glue connecting our...functions to the actions required of an efficient and quality -driven project process. You'll experience a broad range of… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …all programming tasks required to support Data Management and Biostatistics, as necessary.Perform validation and QC/ QA of CDISC, SDTM domain output in accordance ... areas centered around rare diseases and immune disorders.Summary The Manager / Senior Manager , Data Programmer is...collaborating with CROs and other vendors to ensure high quality deliverables to support drug development processes and global… 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 ... improve team engagement & performance Drive Mdev LCM and QA requirements at the site ensuring a high level...processes and roles are established and capable to meet quality specifications & requirements, to include GMP Compliance 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
- Bering Straits Native Corporation (Jamestown, ND)
- …maintains ERDC validationLab Manager manages the activities of Quality Assurance personnel to ensure USACE QA goals are achievedThe Pipestem Dam spillway ... James town, North Dakota.The Lab is under construction. The Project Engineer Lab Manager will participate in the certification and validation through the… more
- Amerant Bank (Miramar, FL)
- …Compliance Risk Assessment, Fair and Responsible Banking, change management and Compliance Quality Assurance ) carried out by second line of defense and ... compliance audits performed by in house staff or an outsourced firm and the validation work related to issues identified in Compliance audits. This role will assist… more
- ASSA ABLOY Americas (Memphis, TN)
- …Support, provide technical leadership subject matter expertise that supports operations related quality assurance , 8D root cause analysis, and production work ... Support, provide technical leadership subject matter expertise that supports operations related quality assurance , 8D root cause analysis, and production work… more
- Russell Tobin & Associates (Austin, TX)
- …locales, using our in-house tools. Collect feedback from various stakeholders to establish quality requirements and connect with the Localization QA team when ... What are we looking for in our Terminology Manager (Project Coordinator II)? Job Title: Terminology Manager (Project coordinator)Duration: 12+ monthsLocation:… more
- Headway Technologies, Inc. (Milpitas, CA)
- TITLE: MANUFACTURING AUTOMATION ENGINEER FLSA STATUS: EXEMPT REPORTS TO: SR. MANAGER , AUTOMATION ENGINEERING SUMMARY: Under the direction of the Sr. Manager of ... and software; meets with vendors and assists with the implementation and validation of new systemsAdministers and maintains ARTIST system, including Oracle DB,… more
