- 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 ... help us make what matters. The Position Plan, manage & perform laboratory validation activities. Routine review of laboratory validation procedures & completed … more
- Novo Nordisk Inc. (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 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 ... problems solving Understand & execute GMP & compliance protocols for instrument validation Executes work according to schedule & department plan Evaluates instrument… more
- Merck & Co. (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… more
- Merck & Co. (Durham, NC)
- …manufacturing systems, in partnership with maintenance, technical operations, operations, validation , and quality personnel.Performs routine system monitoring ... is a member of the Automation team responsible for the support of process control systems used in manufacturing operations located in Durham, NC.- We use a variety… more
- Piper Companies (Holly Springs, NC)
- …Engineer to join a pharmaceutical organization in the Raleigh, North Carolina area . The Automation Engineer will be leading projects for DeltaV integration, ... automation validation , and replicating current processes from other company sites....Monday-Friday, hybrid opportunity located in the Greater Raleigh, NC area .Responsibilities of the Automation Engineer include:Serve as main point… 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 ... 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
- Sumitomo Pharma (Raleigh, NC)
- …products), and therapeutic area (eg oncology, urology, regenerative medicine) within Quality Control a plus. + Advanced knowledge of GMP manufacturing and/or ... **Associate Director, GMP Quality Control ** Sumitomo Pharma America (SMPA)...validation , transfer, and stability studies consistent with regulatory, quality , and pharmaceutical best practices (eg, USP, ICH). +… 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)
- …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 (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
- 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)
- …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
- Grifols Shared Services North America, Inc (Clayton, NC)
- …teams. + Capable of adhering to Good Manufacturing Practices (GxP) - Compliance, Change Control , Quality Oversight, Validation . + After hours support may be ... provides automation support for projects or within a specific area , or provide validation support for automation...adhering to Good Manufacturing Practices (GxP) - Compliance, Change Control , Quality Oversight, Validation . +… 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
- Grifols Shared Services North America, Inc (Clayton, NC)
- …roles (such as author, reviewer, approver, administrator or coordinator) in all quality systems such as Change Control , Discrepancy Management, Quarantine, Batch ... Module, Documentation, and Annual Product Reviews as well as provide Quality input for Validation projects, capital engineering projects, clinical studies,… 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
- 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
