- Catalent (San Diego, CA)
- …, Quality AssurancePosition Summary:Catalent Pharma in San Diego, CA is hiring a Senior Manager of Quality Assurance (QA) at our Clinical Supplies facility. As a ... member of the Site Leadership Team, you will partner with the General Manager to create and sustain a site culture of Safety, Quality performance, Operational… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …and contract compliance. Relationships This individual contributor role reports to the Sr. Manager of Business Assurance and works closely with various teams in ... The Position This position is part of the business assurance function for Commercial, Part D, & Managed Care...Part D rebates as well as effectuating all business assurance initiatives including but not limited to utilization management… more
- Novo Nordisk Inc. (Durham, NC)
- …duties & QA presence & process confirmation on shop floor. Relationships Manager , Quality Assurance . Essential Functions Ensures site compliance with ... Regulations, ISO standards, corporate & local SOPs Reviews & approves documentation for Quality approval - components/raw material, batch records, change control requests, deviations & validation documents Performs QA presence & process confirmation on shop… 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 ... Regulations, ISO standards, corporate & local SOPs Reviews & approves documentation for Quality approval - batch records & other documentation Supports & reviews investigations & root-cause analysis Participates in process confirmations & Go Look Sees Follow… 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 ... lyophilization, product inspection, and quality control laboratories. The Quality Assurance Specialist will support this expansion. Project activities requiring… more
- Catalent (St. Petersburg, FL)
- …metrics, including DRB (Deviation Review Board) presentation.Effective communication with Quality Assurance Supervisor and Manager regarding status of daily ... I. Department Overview: The Quality Assurance Department is responsible for providing leadership and...for the QA Specialists.Provides feedback to QA Supervisor and Manager on performance of QA Specialists.Responsible for actively identifying… more
- Novo Nordisk Inc. (West Lebanon, IN)
- …to certify compliance with specifications and procedures Releases product based on Quality Assurance record review and approval by QA Manager Performs regular ... a leading international regulatory agency preferred As applicable, experience with Quality Assurance oversight and support for all phases of Clinical and Production… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …in 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 exempt level position with responsibilities...working in an aseptic manufacturing facility, preferably in quality assurance , manufacturing compliance, clinical quality, or cell therapy. A… 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 Department has ... within the Catalent St. Petersburg site. The QA Product Manager is responsible for the overall Quality Assurance... Manager is responsible for the overall Quality Assurance review and approval of all technical documents including… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …for CSV projects. Work within a risk-based framework (Computer Software Assurance (CSA)) that is compliant with global regulatory expectations and business ... Practices (GAMP5) and Good Practices Guides, Risk-Based Approach/Computer Software Assurance (RBA/CSA) to assure related Daiichi Sankyo business needs are… more
- Merck & Co. (Ames, IA)
- …of product to customers, ie International Registration, Quality Control, Quality Assurance , Production, etc.Provide Sales force training as well as guidance on ... product implementation for external customers.Education Minimum Requirement:Must have a Doctor of Veterinary Medicine (DVM) degree and (or) PhD in Cattle specific animal science.-Preferred Experience and Skills**:Must have minimum of 2 years related dairy… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …(eg, clinical overviews, formulary dossiers, online evidence repository) Performs quality assurance review of after-hours calls handled by vendor and serves as ... backup for complex after hours inquiries from healthcare professionals Ensures compliance with FDA requirements as they affect Medical Communications; responses must be accurate, up-to-date, balanced, and scientific Provides review for Promotional Review Board… more
- Tris Pharma (Monmouth Junction, NJ)
- …in Monmouth Junction, New Jersey, Tris has an immediate opening for a Manager , Quality Management Systems (QMS). Summary:The Manager , Quality Management Systems ... (QMS) supports, oversees and manages the Quality Assurance (QA) Investigations and Product Quality Complaints Team to...(minimum 3 of those years in a supervisory or manager role) Special knowledge or skills needed and/or licenses… more
- Novo Nordisk Inc. (Boulder, CO)
- …driving change. Are you ready to make a difference? The Position Experienced Project Manager that can manage complex projects within budget, on time, & within scope. ... & other stakeholders, & presentation in steering groups Support local Quality Assurance unit activities Business Process Improvements: Manage activities of the local… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …experience working in an aseptic manufacturing facility, preferably in quality assurance , manufacturing compliance, clinical quality, or cell therapy. A minimum of ... 2 years of leadership experience is preferred. GxP Quality System knowledge, including relevant regulations and guidances (eg 21 CFR parts 210, 211, 1271, 600, 601, 610, ICH Q10, EU GDP/GMP, Part 11/Annex 11, PIC/S, MHRA). Strong written and verbal… more
- Novo Nordisk Inc. (West Lebanon, IN)
- …eligible for selected candidate. Relationships Reports to: Sr. Operational Excellence Manager plus additional interfacing with Manager of Automation Engineering ... Work closely with Engineering, Automation, Validation, IT, Manufacturing, Quality Assurance and Quality Control, on project teams to facilitate design,… more
- Brittmoore Manufacturing, LLC (Houston, TX)
- …plant located in the Northwest part of Houston, is looking to hire a plant manager whose duties include but are not limited to: Schedule and oversee warehouse team, ... delivery of packages Supervise daily warehouse activities, including quality assurance , inventory control, space management, logistics, floor productivity, shipping,… more
- Exela Pharma Sciences, LLC (Lenoir, NC)
- …unit operations, process control systems, computer systems, equipment cleaning, sterility assurance , process, hazards, and safety is a plus Ability to work ... with others, understanding requirements of material receipt, manufacture, test and release as well as CGMP requirements for commercial productionAdvanced computer skills with spreadsheets, word processing, and databasesKnowledge of Microsoft Project or similar… more
- Novo Nordisk Inc. (Boulder, CO)
- …Relationships The Technical Team Lead, API Manufacturing reports to the Senior Manager , API Manufacturing. The Technical Team Lead works with Chemical Development, ... Analytical Services, Engineering, Facilities, EH&S, Program Management and Quality Assurance . The Technical Team Lead, API Manufacturing acts as a delegate for the… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …or material handling tasks in a backup role, as needed. Updates supervisor/ manager of work status or problems with recommendations for improvement or correction. ... quality and operations counterparts that include Manufacturing Operations, Quality Assurance , Engineering and Validation, Quality Control and Warehouse Operations.… more
