- Merck & Co. (Durham, NC)
- …active ingredient, finished product, and laboratory testing for the BCG vaccine.The Senior Specialist , Quality Control participates in a team of analysts in the ... assay validation, equipment validation, and GMP laboratory readiness.- The Senior Specialist , Quality Control will be responsible for starting testing… more
- Merck & Co. (Durham, NC)
- …investigation and CAPA experience, Batch Record Review, Validation IQ, OQ, PQ, Change Control .Has in-depth knowledge of cGMPs and domestic and international ... Job DescriptionSenior Specialist Quality AssuranceSenior Specialist , Quality Systems and Compliance (P3)Our company is expanding its global recombinant… more
- Biomat USA, Inc. (Research Triangle Park, NC)
- …is a hybrid role based out of our RTP, NC office.** **Summary:** Processes change control requests to ensure that process and documentation changes with the ... and all policies, guidelines, and standard operating procedures (SOPs) related to change control . + Processes change control request documentation… more
- Merck (Durham, NC)
- …active ingredient, finished product, and laboratory testing for the BCG vaccine. The Senior Specialist , Quality Control participates in a team of analysts in the ... assay validation, equipment validation, and GMP laboratory readiness. The Senior Specialist , Quality Control will be responsible for starting testing… more
- Fujifilm (Holly Springs, NC)
- …Polymerase Chain Reaction),Spectrophotometry, Mass Spectrometry. * Experience using quality systems (eg, deviation managementsystem, change control , ... * Experience using quality systems (eg, deviation management system, change control , corrective and preventive action (CAPA), document management system)… more
- Veterans Affairs, Veterans Health Administration (Durham, NC)
- …Not authorized Position Description/PD#: Supervisory Inventory Mgt Specialist /PD99825S Relocation/Recruitment Incentives: Not Authorized Permanent Change ... Summary This position serves as a Supervisory Inventory Management Specialist for expendable (NX) assets/materials for the Logistics Service within the VA Health… more
- Army National Guard Units (Raleigh, NC)
- …TITLE 32 EXCEPTED SERVICE POSITION. This National Guard position is for a CONTRACT SPECIALIST (TITLE 32), Position Description Number D2622000 and is part of the NC ... is to perform developmental assignments 11/12.** Responsibilities As a CONTRACT SPECIALIST , GS-1102-11, you will plan the overall approach to meet contracting… more
- Fujifilm (Holly Springs, NC)
- …QC Compliance is responsible for partnering in the Quality oversight of the Quality Control area. The QA Specialist helps drive Quality oversight for the ... of system and process modifications and maintains oversight of change management processes to ensure laboratory systems ...of change management processes to ensure laboratory systems are first validated, and then maintained in a… more
- Fujifilm (Holly Springs, NC)
- …* Experience using quality systems (eg, deviation management system, change control , corrective and preventive action (CAPA), document management system) ... United States. **Job Description** **About the Role** The Sr. Specialist 2, QC Program Management Technical transfer (TT) and...Plans and QC Specifications. * Leads, authors, and reviews change controls of QC Sample Plans for both internal… more
- Merck (Durham, NC)
- …management. + Strong oral and written communication skills. + Experience with key manufacturing change control compliance systems such as Veeva and/or other ... + Technology & Product Transfers, Qualifications, Validations, Process Improvements, and Change Control . + Assurance of compliant packaging process execution… more
- Novo Nordisk (Clayton, NC)
- …activities/improvement of standards within the assigned process + Review & approves change control documentation, SOPs & other current good manufacturing ... in one or more of the following: product disposition, DV/CAPA, Change Control , Audits, Supplier Management, Project Management, Validation, laboratory method… more
- Lilly (Durham, NC)
- …with environmental permits. + Understand and support the HSE event, CAPA and change control processes, and influence application of the hierarchy of controls ... manufacturing site from the ground up. The Health, Safety, Environmental (HSE) Specialist will be responsible for the development and technical support of HSE… more
- Novo Nordisk (Clayton, NC)
- …Identify process improvements before equipment, systems or processes are placed under change control during validation + Budget oversight as needed + Other ... for IV, OV & PV protocols + Ownership of Change Requests (CR's) related to project validation responsibilities +...assigned IV, OV & PV protocols for direct impact systems /processes per approved timeframes. Requires no guidance & direction… more
- Truist (Raleigh, NC)
- …as Certified Information Systems Auditor (CISA), Certified in Risk and Information Systems Control (Information Systems Audit and Control ... performed, both major and minor, which are not mentioned below. Specific activities may change from time to time. 1. Provide independent risk oversight (ie LOD2) for… more
- Novo Nordisk (Clayton, NC)
- …compliance with Regulations, ISO standards, & Corporate/Local SOPs + Review & approve minor change control requests & low complex major change controls + ... reports for release of API materials, minor deviations, minor change controls, review & approval of SOPs, QA presence...+ Review API/Intermediate Batch documentation in various Novo Nordisk systems (eg, LIMs, SAP, NovoGlow, etc.) + Ensure site… more
- BioFire Diagnostics, LLC. (Durham, NC)
- …documentation in a timely manner. + Provide validation support to the Change Control process associated with system changes, re-validation and re-qualification ... tasks associated with manufacturing equipment like autoclaves, fillers, ovens, inspection systems , packaging systems etc. In addition provide support to… more
- Novo Nordisk (Clayton, NC)
- …compliance with Regulations, ISO standards, & Corporate/Local SOPs + Review & approve change control requests + Review & approve deviations guidance to ... of batch reports & release of API materials, deviations, change controls, review & approval of SOPs, QA presence...& approve API/Intermediate Batch documentation in various Novo Nordisk systems (eg, LIMs, SAP, NovoGlow, etc.) + Ensure site… more
- GE Vernova (Cary, NC)
- …* Rapidite des rapports **Job Description** _About Us:_ _Come bring your energy to change the world_ _Grid Solutions, part of the GE Vernova portfolio of energy ... serves customers globally with over 12,000 employees. Grid Solutions provides equipment, systems , and services to bring power reliably and efficiently from the point… more
- GE Vernova (Cary, NC)
- …* Timeliness of reporting **Job Description** About Us: Come bring your energy to change the world Grid Solutions, part of the GE Vernova portfolio of energy ... serves customers globally with over 12,000 employees. Grid Solutions provides equipment, systems , and services to bring power reliably and efficiently from the point… more
- Southern Company (Durham, NC)
- …years of commercial/industrial experience working on Generators, ATS/switchgear, and Paralleling Control systems . * Experience in reading and understanding ... PowerGen Products. * Ability to troubleshooting Switchgear and/or PowerGen equipment and systems . * Ability to understand and follow project scopes. * Working… more
