- Insmed Incorporated (San Diego, CA)
- …self and designated back up.Support inspection and client audit readiness plans. Serve as subject matter expert for stability and sample management related ... paced, collaborative, and multidisciplinary team. This individual will join the Quality Control leadership team. As the QC Stability and Sample Management… more
- Aequor (Providence, RI)
- …you will provide support to the Product Quality (PQ) organization as a subject matter expert of clinical and commercial product stability studies and ... Team by collaborating with diverse functional areas including Supply Chain, Manufacturing, Quality Control , Regulatory, Quality Assurance, Quality … more
- Insmed Incorporated (San Diego, CA)
- …and approval of GMP analytical records. Will also provide QA support for GTx Quality Control laboratories. This position is onsite/hybrid and based in San Diego, ... CaliforniaResponsibilitiesQA support of Quality Control :Approve or reject starting materials, packaging...out of trend and out of specification investigations, Change Control and CAPA/Effectiveness Checks. Provide expert QA… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …quality team in support of site improvement projects and strategies.Be a Subject Matter Expert on quality assurance topics within the group in support ... responsibilities for providing quality oversight over the site Quality Control laboratories responsible for testing of pre-clinical, clinical, and commercial… more
- Merck & Co. (Rahway, NJ)
- …lead.Track-record of independent problem-solving.Applying microbiology expertise as a subject matter expert for quality controlInteracting with internal ... of the laboratory, ensuring compliance with safety regulations, maintaining quality control , and managing a team of...Policy - Job Posting and Employee Placement, all employees subject to this policy are required to have a… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …includes Customer Care, Patient Support Hubs, and Patient Assistance Programs Serve as the Subject Matter Expert ( SME ) across diverse functional areas, ... Ability to operate in a fast-paced matrixed environment with a quality control focus and a documentation orientation Creative problem-solving with ability to… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …will serve as the point of contact for daily distribution of process materials, subject matter expert for operations inventory management and point of ... in the treatment of multiple myeloma.Legend Biotech is seeking Operations Inventory Control Specialist as part of the Technical Operations team based in Raritan,… more
- Merck & Co. (Durham, NC)
- …ensure the right support/awareness is given to issues as they ariseServe as a Subject Matter Expert during tours to provide area/process overview information ... for the problem-solving efforts and solutions offered by other shifts and teamsSubject Matter expert for LOTO and permit writing for maintenance activities,… more
- American Honda Motor Co Inc (Marysville, OH)
- …countermeasures to avoid problem occurrence from production planning through delivery Serve as subject matter expert to support and/or train Delivery ... negative delivery, production, inventory management, plant/equipment, sub-supplier management, packaging control and/or workforce trends within the supply base; and… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …outbound shipments and general warehouse activities as needed.Key Responsibilities Serves as a subject matter expert for inventory management and warehouse ... that will aid in decision making for inventory balances and control processes, and process improvements related to inventory.Monitors inventory life cycle… more
- Novo Nordisk Inc. (West Lebanon, IN)
- …in order to support Process Tracks, GMP partners & Training partners on site. Expert in local change control process to support revision of standards. Interfaces ... including the routing and approval flow in Document Change Control (DCCs) Reviews local Quality Management System...of process improvement methodologies such as LEAN a plus Expert in change control , MS Word &… more
- Exela Pharma Sciences, LLC (Lenoir, NC)
- …major equipment, important systems, instrumentation, and computerized systems.Knowledge of quality systems including exception management, change control , ... of laboratory documentation.Help with the implementation and interpretation of applicable quality and regulatory requirements (eg, FDA, GLP, QSR, cGMP, USP, and… more
- Novo Nordisk Inc. (Durham, NC)
- …to the automation-related specifications & maintenance plans Support audits & inspections as SME for process control systems Coach & train colleagues & ... life-changing careers, and the opportunity to help improve the quality of life for millions of people around the...what matters. The Position Improve reliability of the process control systems to meet current & projected customer, business… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …from control strategies to PVP and PPQ templatesServe as an SME for global initiatives related to quality /compliance/validation (APS benchmarking, Validation ... will extend to participation in a variety of cross functional CMC and quality forum under the Joint Manufacturing Committee in the commercial governance structure.… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …Readiness and Support (Front/Backroom)Site Escalations Support acting as MES SME (s)MES Training Curriculum Ownership and UpdatesDelivery of Raritan Site ProjectsThis ... Therapy cGMP manufacturing and supervisory experience preferredProvide technical expertise of Change Control process as well as oversight of the MES team to ensure… more
- WuXi AppTec (Philadelphia, PA)
- … Control and Process Development groups. As needed,interacts with internal/external subject matter experts ( SME 's), material/equipment vendors and ... processes, operations and organizational structure to determine time or quality revisions and suggest improvements.Assists with capital improvements.Generates high … more
- OSI Group (Aurora, IL)
- …The expectation is that the person in this position will become a dry sausage subject matter expert for OSI.This position is tasked with looking into ... ability to operate in a fast-paced, high-energy environment.* Assists with Quality Control programs to safeguard product quality .* Conducts internal audits… more
- Arthrex (Fort Myers, FL)
- …automation suites, and implement technologies, enhancements, and incident/problem resolutions. Viewed as a subject matter expert in the field within the ... information. Support user acceptance testing and user training activities. Adhere to the Quality System Procedures and Change Control . Lead and/or participate in… more
- Dexian - DISYS (Cary, IL)
- …of trends, statistical control of processes to allow cost saving * Subject matter expert to internal & external regulatory requirements, (including ... (potential extension)Location : Cary IL Qualifications * Relentless about quality , people who thrive in a fast-paced environment and...Corporate, FDA, ISO, MDD, and individual country regulatory requirements) Subject matter expert to local… more
- Credit Acceptance Corporation (Atlanta, GA)
- …account details clearly and efficiently in various required system applicationsUnderstand and become a subject matter expert of all data systems to research ... Place to Work culture. Through the consistent delivery of quality services and understanding the needs of our business,...accurate and balance to end of day reportingBecome a subject matter expert to provide… more
