- Merck & Co. (Durham, NC)
- …proceed in compliance with cGMP, regulations, and our Company's Quality Management System.Supporting areas such as Design, Commissioning, Qualification and ... lyophilization, product inspection, and quality control laboratories. The Quality Assurance Specialist will support this expansion. Project activities… more
- Novo Nordisk Inc. (Durham, NC)
- …the Batch Review Processes required Understanding of validation preferred Understanding of quality management systems required Understanding of quality ... oversight & on floor production support required Knowledge in Quality Management Systems Demonstrated knowledge of critical controls & input/output requirements… more
- Novo Nordisk Inc. (Durham, NC)
- …industry General knowledge of Batch Review Processes (BRP), validation processes and Quality Management Systems (QMS) preferred General knowledge of quality ... and QA presence & process confirmation on shop floor. Relationships Manager, Quality Assurance. Essential Functions Ensures site compliance with Regulations, ISO… 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 ... with IT, metrology & other key stakeholders to ensure the right quality , cost & timely completion of all deliverables. Relationships Manager. Essential Functions… more
- Merck & Co. (Rahway, NJ)
- …(SOP) and cGMP documents.Experience with Quality SystemsExperience in supporting compliance investigations and change management .Familiarity with US and EU ... a fast-paced job that provides a high degree of technical and project management responsibility. The Senior Specialist - Manufacturing Automation position will… more
- Novo Nordisk Inc. (Boulder, CO)
- …with Chemical Development, Analytical Services, Engineering, Facilities, EH&S, Program Management and Quality Assurance. Essential Functions Responsible for ... to support analytical and process development, the CMC team works alongside Quality , Regulatory, Technical Operations and RNAi Early Development professionals at our… more
- BioAgilytix (Boston, MA)
- …to the patients who need them.We're seeking a detail-oriented and proactive Corporate Compliance Specialist to join our team. In this role, you'll play ... love to hear from you!Essential ResponsibilitiesParticipates in the monitoring of the Quality Management Systems (QMS), including, but not limited to, Vendor… more
- Merck & Co. (Durham, NC)
- …issues to improve manufacturing performance, and maintaining the automation systems in compliance with cGMPs. The Manufacturing Automation Sr. Specialist must ... quality , IT, and engineering groups. - The Senior Specialist for Manufacturing Automation is responsible for providing automation technical support… more
- Merck & Co. (Rahway, NJ)
- …to work in a fast-paced job that provides both technical and project management responsibility. The Specialist - Manufacturing Automation position will report to ... production, utility systems and associated infrastructure.- Responsibilities of the Specialist - Manufacturing Automation include the following:Site Operations (GWES)… more
- Catalent (Manassas, VA)
- … Specialist - 2nd Shift is responsible for creating and maintaining the Quality System documentation. Communicate any deviations to management . Assist the ... all non-conformance to support continuous improvement efforts; Document all areas of non- compliance with the Quality System and ensure corrective action is… more
- Catalent (Manassas, VA)
- …with complex formulations to help create engaging new products consumers will love.The Quality Assurance Specialist I - Quarantine is responsible for auditing ... of production and packaging to ensure adherence to company quality standards. Communicate any deviations to management ....Quality Plan (FQP) standards and responsible for ensuring compliance to FDA and cGMP standards for Quality… more
- Merck & Co. (Rahway, NJ)
- …(including walkthroughs and sample testing) in line with the established quality standards and timelines.Conduct IT policy compliance , system implementation, ... A successful incumbent will be well versed in SAP, cloud infrastructure, access management , network operations and in the System Development Life Cycle (SDLC) and to… more
- Merck & Co. (Rahway, NJ)
- …print solutions. Additional responsibilities include support of printer configuration, management and security configuration.The incumbent will also be responsible ... and software vendors in order to set global standards and perform lifecycle management of bar code printers and software systems. The engineer will also look… more
- Catalent (St. Petersburg, FL)
- … enhancements/improvements and leading project to deliver solutions.Collaborates with management and supervisory personnel from operations, quality control ... I. Department Overview: The Quality Assurance Department is responsible for providing leadership...environment within the manufacturing area by overseeing and ensuring compliance with current Good Manufacturing Practices and Standard Operating… 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 ... & participates in systematic problems solving Understand & execute GMP & compliance protocols for instrument validation Executes work according to schedule &… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …difference? The Position Responsible for upholding and promoting the Novo Nordisk (NN) Quality Management System (QMS) as the framework that enables the company ... needs and expectations of internal/external stakeholders, striving for simplicity, making quality a proactive consideration, ensuring compliance with relevant… more
- BioAgilytix (Durham, NC)
- …make and share observations in a considerate mannerProficiency in LIMS and Quality Management software packagesBENEFITS AND OTHER PERKSMedical Insurance (HDHP ... then you'll be right at home here at BioAgilytix.Essential ResponsibilitiesPerform Quality Control (QC) technical, scientific, and compliance review of… more
- Novo Nordisk Inc. (Boulder, CO)
- …to support analytical and process development, the CMC team works alongside Quality , Regulatory, Technical Operations and RNAi Early Development professionals at our ... applicable environmental, health and safety regulations. Relationships Reports to Senior Specialist EHS at US headquarters in MA. Internal relationships include… more
- Merck & Co. (Rahway, NJ)
- …in supporting the process automation systems within clinical manufacturing.-The Automation Specialist - Engineering Auto Eng position will report to the Director, ... designing, implementing, and maintaining automated manufacturing process systems in compliance with industry regulations and standards. Your contribution will be… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …focused on an EHS first mindset, a Right First Time culture of quality , permanent inspection readiness compliance mindset and passionately drives continuous ... of multiple myeloma. Legend Biotech is seeking a Metrology Specialist as part of the Maintenance & Metrologyteam based...facility. Partner and manage relationships with contractors to ensure quality of work and compliance with all… more
