- Merck & Co. (Durham, NC)
- …and quality control laboratories.The Quality Assurance Manager will direct Shop Floor Quality Assurance (SFQA) B160 to support process and technology introduction, ... product.- The focus for the position includes all aspects of Shop Floor QA oversight supporting Second Shift (Evening Shift). Responsibilities Reporting to the… more
- Merck & Co. (Durham, NC)
- …with cGMP, regulations, and our Company's Quality Management System. Provide QA shop floor support in the execution and review of GMP documentation such as IQ, ... and other technical documents to meet schedule milestones. Provide QA shop floor support on batch review, alarm response, incursion response and deviation… more
- Merck & Co. (Durham, NC)
- …performance of job dutiesActively supports safety initiatives, including shop floor audits, lockout/tagout and Hazardous Energy Control Procedure updatesEducation ... 50 lbs, climb ladders and stairs, work on platforms and equipment above floor level. Walking, bending, crawling, and stooping is required.-Night Shift 12.5 Hour… more
- Merck & Co. (Durham, NC)
- …control. Supports regulatory inspection activities for the facility Provides on-the- floor support of operational and technical (process/equipment) issues on the ... shop floor . Completes projects to improve the performance of our processes, including investigation Corrective/Preventative Actions (CAPAs), projects aimed at… more
- Novo Nordisk Inc. (Durham, NC)
- …LoB). Performs archiving duties and QA presence & process confirmation on shop floor . This position works closely with production. The schedule is Monday - Thursday ... Management Systems (QMS) preferred General knowledge of quality oversight & on floor production support preferred Good written & verbal communication skills required… more
- Merck & Co. (Rahway, NJ)
- …robust processing, continuous improvement, and cross-functional team building.Providing on-the- floor support of operational and technical issues; providing immediate ... responses on the shop floor to deviations and potential deviations.Completing projects to improve the performance of our processes, including continuous process… more
- Merck & Co. (Baton Rouge, LA)
- …Operations, Quality and Technical organizations to resolve complex problems.On- floor support of manufacturing activities.Identify and implement process/equipment ... investigations of automation anomalies to prevent a recurrence, which includes on-the- floor support of manufacturing activities.Lead in the development of technical… more
- Merck & Co. (Rahway, NJ)
- …networks compliant with ISA/IEC 62443 standards.Be the SME for our Shop Floor Network (Manufacturing division Core eventually migrated to Restricted LFN) firewall ... rules.- Be the point person for changes to these rules, and evaluation of impact to automation systems with IT driven firewall rule changes.Lead/assist project scopes, define IT and infrastructure deliverables, timelines and estimates for a wide array of… more
- Merck & Co. (Durham, NC)
- …- Experience training others through hands-on training - Experience with on-the- floor cGMP manufacturing and f amiliarity with regulatory requirements - Demonstrated ... ability to work both independently and as a part of a team - - Travel : 0% - #MSJR VETJOBS Current Employees apply HERE Current Contingent Workers apply HERE US and Puerto Rico Residents Only:Our company is committed to inclusion, ensuring that candidates can… more
- Aequor (Libertyville, IL)
- …and Quality System disciplines. The candidate needs to understand shop floor activities, Good Manufacturing Practices (GMPs), electronic change management, and ... process automation in addition to prior manufacturing systems development and support. DUTIES AND RESPONSIBILITIES:Support the IT Quality & Compliance for the Cell Therapy Vector manufacturing site.Take ownership of deviations, CAPAs, and investigations… more
- Merck & Co. (Durham, NC)
- …Experience training others through hands-on training Experience with on-the- floor cGMP manufacturing and familiarity with regulatory requirements Demonstrated ... ability to work both independently and as a part of a team Travel : 0% #MSJR VETJOBS Current Employees apply HERE Current Contingent Workers apply HERE US and Puerto Rico Residents Only:Our company is committed to inclusion, ensuring that candidates can engage… more
- Merck & Co. (Durham, NC)
- …and collect team feedbackProvide clear consistent communication between all shop floor process areas.Escalate issues as needed to ensure the right support/awareness ... is given to issues as they ariseServe as an SME during tours to provide area/process overview information to visitors/auditors upon request. Quality & Safety Compliance Foster strong safety culture on the team through actions, coaching, and prioritizationCoach… more
- Novo Nordisk Inc. (West Lebanon, IN)
- …ancillary support records. Will be a QA presence on the manufacturing floor . Relationships Reports to: According to the organizational chart Number of subordinates ... with direct/indirect referral: n/a Essential Functions Performs walk-through audits of NNUSBPI Manufacturing facilities Releases product based on Quality Assurance record review and approval by Manager, Quality Assurance Review and assess Corrective and… more
- Merck & Co. (Durham, NC)
- …successful candidate will interact directly with Quality Operations (QO), Shop Floor Quality Assurance (SFQA), Sterility Assurance (SA), Engineering Maintenance Site ... Services (EMSS), and Warehouse Operations, and Quality Assurance colleagues as directed in support of Project Flash. This position will support the technical roles of Quality in collaboration, review, and approval of cGMP documentation in the following areas:-… more
- Novo Nordisk Inc. (West Lebanon, IN)
- …support records. Will be a QA presence on the manufacturing floor . Relationships Quality Assurance. Essential Functions Reviews all manufacturing and support ... records to certify compliance with specifications and procedures Releases product based on Quality Assurance record review and approval by QA Manager Performs regular internal audits of NNUSBPI facilities as a lead auditor Works closely with Manufacturing and… more
- Merck & Co. (Durham, NC)
- …change controls, SOPs, validation protocols, technical reports. Provide QA shop floor support on Aseptic techniques, aseptic observations, cleaning techniques, and ... gowning observations. Partner with site functions to solve problems and achieve goals. Makes decisions guided by policies and procedures that impact the team's ability to meet performance objectives. Consults on an as-needed basis with next level manager on… more
- Merck & Co. (Rahway, NJ)
- …omics, machine learning; experience integrating PAT efforts)Experience with on-the- floor Good Manufacturing Practice (GMP) manufacturing support, familiarity with ... manufacturing batch record reviews and/or operations.Experience with mathematical modeling, theoretical scaling calculations, drug substance comparability, scale down establishment, computational fluid dynamics (CFD) modeling, Quality by Design (QbD) and Lean… more
- Merck & Co. (Durham, NC)
- …Sterile manufacturing experienceAseptic Gowning knowledge and techniquePrevious shop floor quality, quality control or quality assurance experienceExperience with ... presenting and interacting with inspectors during regulatory audits.Ability to develop systems and teach/develop new employees.Experience in GMP biologics manufacturing facilities, including preparation of PQ protocols, validation protocols and regulatory… more
- Exela Pharma Sciences, LLC (Lenoir, NC)
- …required. The Aseptic Manufacturing Technician will actively participate on the production floor by working with a team of manufacturing professionals and performing ... aseptic interventions, environmental monitoring, and other microbiology and operational tasks. This newly created position offers a unique opportunity to microbiology professionals a non-traditional (outside the lab) pathway to advance rapidly in the… more
- Exela Pharma Sciences, LLC (Lenoir, NC)
- …required. The Aseptic Manufacturing Lead will actively participate on the production floor by leading a team of manufacturing professionals and performing aseptic ... interventions, environmental monitoring, and other microbiology and operational tasks. This role requires strong leadership skills and the ability to collaborate effectively with cross-functional teams. This newly created position offers a unique opportunity… more
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