- Merck (Durham, NC)
- …Engineer will provide organizational support and technical leadership for the Teknika manufacturing area in Durham, NC. The Validation group at Teknika is a ... validation documents to support regulatory filings + Support Change Control documentation for complex process, validation , analytical, equipment,… more
- Novo Nordisk (Clayton, NC)
- …& quality systems (eg, product disposition, Deviations/CAPA, Change Control , Audits, Supplier Management, Project Management, Validation , etc.) required ... QC across all production areas in Product Supply. The area is anchored in Product Supply, Quality ...Person), if role is in batch release. Serve as Quality oversight, review & approval of validation … more
- Novo Nordisk (Clayton, NC)
- …with regulations. Has product release authority if role is in batch release. Quality oversight, review & approval of validation activities and documents ... in one or more of the following: product disposition, DV/CAPA, Change Control , Audits, Supplier Management, Project Management, Validation , laboratory method and… more
- Novo Nordisk (Clayton, NC)
- …& quality systems (eg, product disposition, Deviations/CAPA, Change Control , Audits, Supplier Management, Project Management, Validation , etc.) required ... authority (Authorized Qualified Person), if role is in batch release. Serve as Quality oversight, review & approval of validation activities associated with… more
- Novo Nordisk (Clayton, NC)
- …the current NN procedures & requirements from health authorities are reflected in the validation planning & quality related decisions + Support validation ... standards, & Corporate/Local SOPs + Review & approve change control requests + Review & approve deviations + guidance...support required + Strong knowledge level in cGMP's & validation required + Strong knowledge in Quality … more
- Lilly (Durham, NC)
- …and qualification activities. In addition, cross-train in the visual inspection area to support collaborative quality and production team environment. ... qualification / validation documents for equipment to ensure compliance with quality standards. + Liaison with Lilly support groups and external partners to… more
- Grifols Shared Services North America, Inc (Clayton, NC)
- …standards and control program within the laboratory + Overseeing the validation of new test methods (includes drafting protocols, execution and drafting final ... to SOP and/or best practices and develops solutions to defined problems within area of assignments; Communicates effectively and promptly with all levels of the… more
- Cambrex High Point (Durham, NC)
- …customer-focused scientific and manufacturing excellence, as well as our strong commitment to quality and safety, we offer a range of career and growth opportunities ... our global network of locations. Together with our customers, we aim to improve the quality of life for patients around the world. Start a career where You Matter by… more
- IQVIA (Durham, NC)
- …with appropriate supervision. + Statistical Analysis Plan (SAP) and Shells: Authors or performs quality control review (QC) of SAPs and shells. Make best use of ... tasks with a focus on accuracy. Conducts all appropriate validation requirements, according to Standard Operating Procedures (SOPs), for...report form (CRF) review. + Protocol: Authors or performs quality control (QC) review of the statistical… more
- PruittHealth (Raleigh, NC)
- …She/he is responsible for planning and directing clinical operations and quality improvement practices for designated centers. The senior nurse consultant provides ... education, mentoring and validation of required systems and processes for each center,...achieve and sustain compliance with all applicable regulations and quality outcomes. **KEY RESPONSIBILITIES:** * Annually in collaboration with… more
- Lilly (Durham, NC)
- …process improvement initiatives for Plant Process Teams as representative of the Quality function. + Approve commissioning qualification / validation documents ... make life better for people around the world. **Position Description:** The Quality Assurance Representative for the Device Assembly and Packaging team provides… more
- Merck (Durham, NC)
- …written documentation of activities. Responsible for SAP transactions and change control activities including spare part lists and Preventative Maintenance (PMs) ... embraces an inclusive team culture including significant interaction with Operations, Quality , Automation, Technology, and other groups as required.The HVAC&R Lead… more
- Novo Nordisk (Clayton, NC)
- …fill & finish warehousing, and QC across all production areas in Product Supply. The area is anchored in Product Supply, Quality & IT, which globally employ ... plant facilities & site support systems from a centralized control center for the FFEx facility. Prioritize, communicate &...including troubleshooting & optimization activities + Adhere to all quality & environmental regulations within area of… more
- Amgen (Holly Springs, NC)
- …+ Responsibilities include optimally delivering to the site, process development team, and quality control through rapid and robust analytical testing + Ensure ... analytical support to functions including but not limited to Drug Substance, Quality , and Manufacturing + Understand analytical methodologies to detect product … more
- Grifols Shared Services North America, Inc (Clayton, NC)
- …Capable of adhering to Good Manufacturing Practices (GxP) - Compliance, Change Control , Quality Oversight, Validation . **Education and Experience ... construction and start-up: + Design of low voltage power distribution and motor control . + Responsible for selection and sizing of instrumentation based on P&IDs. +… more
- Merck (Durham, NC)
- …is responsible for managing the team in Durham, NC facility for the assigned area process control systems, while actively supporting an inclusive team culture. ... incidents, Quality Notifications (QNs), system commissioning and qualification, change control , and other key automation related processes + Assisting in the… more
- Novo Nordisk (Clayton, NC)
- …fill & finish warehousing, and QC across all production areas in Product Supply. The area is anchored in Product Supply, Quality & IT, which globally employ ... reviews & support equipment installation, commissioning & qualifications + Assist in maintaining quality & schedule within area of responsibility + Establish &… more
- Grifols Shared Services North America, Inc (Clayton, NC)
- …career path. Designs and operates manufacturing technology for the organization. Supervises quality control and oversees the fulfillment of FDA regulations. ... environment. Designs and operates manufacturing technology for the organization. Supervises quality control and oversees the fulfillment of FDA regulations.… more
- Novo Nordisk (Clayton, NC)
- …fill & finish warehousing, and QC across all production areas in Product Supply. The area is anchored in Product Supply, Quality & IT, which globally employ ... 50,000 employees. FFEx is a newly established and growing area with the responsibility to design, plan, and build...experience and training required + General knowledge of change control systems and Quality Management Systems (QMS)… more
- Truist (Raleigh, NC)
- …Accountable for onboarding CDEs and business metadata, defining appropriate CDE Data Quality rules and controls for their corresponding Data Domain, maintaining, and ... populating the Business Glossary and supporting and resolving Data Quality issues as part of the Data Quality...time to time. 1. Responsibilities include the definition and validation of a business critical process and the associated… more