- 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)
- …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
- 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
- Merck & Co. (Durham, NC)
- …(SME) for issues pertaining to these programs.Author, review, and/or edit validation documents to support regulatory filingsSupport Change Control documentation ... validation practices for products, processes and equipment.Partner with Operations, Quality , and Automation functional areas on validation study… more
- Merck & Co. (Durham, NC)
- …Capital Projects, Maintenance, Safety, Process Development, Technical Services, Utilities and Validation . - Our Company is expanding its global recombinant vaccine ... written documentation of activities. Responsible for SAP transactions and change control activities including spare part lists and Preventative Maintenance (PMs)… 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
- Merck & Co. (Durham, NC)
- …coordination leadership and implementation of troubleshooting activities and change control .Initiate and lead collaboration within the Operations, Quality ... of the Focus Factory Automation team responsible for the assigned process control systems in support of manufacturing operations located in Durham, NC.This… more
- Rose International (Fuquay-Varina, NC)
- …requirements. ** Only qualified Electrical Engineer candidates located in the Fuquay Varina, NC area will be considered due to the role being onsite 5 days per week. ... Utility division on low to medium-complexity engine and transmission electronic control systems for products across our division. Required Education: *… 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
- Astellas Pharma (Sanford, NC)
- …in Biological Sciences with 0-3+ years of relevant industry experience in a quality control role. + Experience in molecular/cell biology required (minimum 1 ... Astellas Center of Excellence for their newly created Genetic Regulation Focus Area . We are currently exploring three gene therapy modalities: gene replacement, exon… 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)
- …validation documents to support regulatory filings + Support Change Control documentation for complex process, validation , analytical, equipment, ... practices for products, processes and equipment. + Partner with Operations, Quality , and Automation functional areas on validation study implementation.… more
- Actalent (Sanford, NC)
- …in product and process planning/design, gage design and service development. Perform all quality PCO/PCR reviews. Drive compliance to Control Plan & PPAP ... Description: * Drive customer focus in area (s) of responsibility by ensuring the voice of...Evaluate process capability and apply appropriate statistical techniques and control methods to meet quality , delivery, and… more
