- Novo Nordisk (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 ... help us make what matters. The Position Plan, manage & perform laboratory validation activities. Routine review of laboratory validation procedures & completed … more
- Novo Nordisk (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 ... problems solving + Understand & execute GMP & compliance protocols for instrument validation + Executes work according to schedule & department plan + Evaluates… 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)
- …Novo Nordisk (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...is required + Strong knowledge level in cGMP's & validation is required + Strong knowledge in Quality… more
- Novo Nordisk (Durham, NC)
- …for Quality approval - components/raw material, batch records, change control requests, deviations & validation documents + Performs QA presence ... shop floor. Handles release of raw materials & provides quality oversight, review & approval of validation ...provides quality oversight, review & approval of validation activities associated with minor changes to existing systems.… more
- Novo Nordisk (Clayton, NC)
- …batch records, change control requests, deviations, , Quality Control (QC) laboratory investigations, SOPs & validation documents + Participate in ... corporate and local standard operating procedures (SOPs)Release of raw materials. Quality oversight, review & approval of validation activities associated… 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 operations including troubleshooting & optimization activities + Adhere to all quality & environmental regulations within area of responsibility + Drive… more
- BD (Becton, Dickinson and Company) (Durham, NC)
- …quality engineering principles (eg acceptance sampling, statistical process control , measurement/test methods, quality planning, failure investigation, design ... hypothesis testing, descriptive statistics, process capability) + Reviews and has Quality Engineering approval authority for new and modified design / process… more
- Merck (Durham, NC)
- …(7) years' experience including prior management experience in a functional area , such as, Operations, Quality , Technical Operations, Technology, Engineering, ... (5) years' experience including prior management experience in a functional area , such as, Operations, Quality , Technical Operations, Technology, Engineering,… 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 7. Overseeing the validation of new test methods (includes drafting protocols, execution and drafting final ... reports) **Requirements:** **_- Sr. Quality Associate I:_** BS/BA degree preferably in a STEM...best practices and develops solutions to defined problems within area of assignments; Communicates effectively and promptly with all… more
- Wolters Kluwer (Raleigh, NC)
- …disease/condition and patient-specific variables. + Perform ongoing clinical data analysis and quality control activities related to proprietary drug content and ... goals. + Maintain a high degree of currency in area (s) of clinical or domain expertise and industry knowledge...Understand the needs and expectations of the assessment and validation of client problem. Ensure quality responses… 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
- 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)
- …or review and approval of system commissioning and qualification documents, change control , automation incidents, Quality Notifications (QNs), and other key ... embrace an empowered team culture including significant interaction with manufacturing, quality , IT, and engineering groups. The Senior Specialist for Manufacturing… more
- Amgen (Holly Springs, NC)
- …Responsibilities include effectively delivering to the site, process development team, and quality control through rapid and robust analytical testing. + Ensure ... Work closely with functions including but not limited to Drug Substance, Quality , and Manufacturing + Understand analytical methodologies to detect product … 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
- Merck (Durham, NC)
- …Projects, Maintenance, Safety, Process Development, Technical Services, Utilities and Validation . Our Company is expanding its global recombinant vaccine production ... written documentation of activities. Responsible for SAP transactions and change control activities including spare part lists and Preventative Maintenance (PMs)… more