- Insmed Incorporated (NJ)
- …for the future of science, we're in. Are you?About the Role:We're looking for a Quality Management System (QMS) Specialist on the Analytical Development team ... metrics on documentation status and compliance using the Veeva Quality Management System to ensure alignment with regulatory and internal quality … more
- Olympus Corporation of the Americas (Westborough, MA)
- …more about Life at Olympus: https://www.olympusamerica.com/careers . **Job Description** The Sr. Regulatory Affairs (RA) Specialist II Digital Health supports ... As part of a high-growth, innovative team, the RA Specialist II will provide regulatory guidance, prepare...systems . As needed provide input to define global regulatory strategy requirements. + Participate in teams for sustaining… more
- The Clorox Company (Durham, NC)
- …**Your role at Clorox:** The Senior Regulatory Specialist will serve as ... cross-functional collaboration is essential, involving teams across Product Safety & Regulatory Affairs (PS&RA), Product Development, Legal, Corporate Quality ,… more
- Merck & Co. (Durham, NC)
- …training to mechanics and other maintenance personnel.Interface with safety, production, and quality groups to ensure facility operations and systems comply with ... of preventative and predictive maintenance programs to assure compliance with quality , regulatory , and reliability requirements and goals.Track maintenance and… more
- Merck & Co. (Durham, NC)
- …of preventative and predictive maintenance programs to assure compliance with quality , regulatory , and reliability requirements and goals. Utilize maintenance ... Projects, Productivity Improvements, Project Management, Regulatory Audits, Regulatory Compliance, Sterile Manufacturing, System Maintenance, Team… more
- Cipla (Fall River, MA)
- …and completeness. Defends the validation programs and strategies to customers and regulatory auditors. Performs weekly quality reviews of Master Control database ... Job Title : Pkg. Documentation Specialist II FLSA Classification : Professional, Exempt Work...company's document and SOP's procedures while ensuring their accuracy, quality , and integrity. This position reports to the Department… more
- Cipla (Fall River, MA)
- …working outside of Cipla's US Subsidiaries or Affiliates. Job Title : Quality Assurance Operation Specialist FLSA Classification : Professional, Exempt Work ... an individual contributor role and a member of the InvaGen Pharmaceuticals Plant Quality Team. The QA operation specialist (MDI) monitors and ensures validation… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …actions.Perform tasks in a manner consistent with the safety policies, quality systems , and cGMP requirements.Drive continuous improvementOther duties may ... immunotherapy in the treatment of multiple myeloma.Legend Biotech is seeking a QA Validation Specialist III as part of the Quality team based in Raritan, NJ.Role… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …skills. cGMP manufacturing.Maintenance, facilities and utilities.Computerized maintenance management systems (CMMS).EHS and regulatory standards (eg EPA, ... in the treatment of multiple myeloma.Legend Biotech is seeking a Maintenance Technician Specialist as part of the Technical Operations team based in Raritan, NJ.Role… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …Biotech is seeking QC Specialist , Lab Services, II/III as part of the Quality team based in Raritan, NJ. Role OverviewThe QC Specialist , Lab Services is ... Biology, Biochemistry, Microbiology, Chemistry or related fieldSolid understanding of regulatory requirements, policies and guidelinesExperience with Quality … more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …labels and documents prior to use on the manufacturing floor.Utilize multiple electronic quality systems , batch records and SAP.Work in a team based, ... multiple myeloma.Legend Biotech is seeking a QA Shop Floor Specialist III as part of the Quality ...as needed.Consistently perform tasks in adherence with safety policies, quality systems , and cGMP requirements, as well… more
- Aequor (Golden Valley, MN)
- Job Title: Packaging Development Specialist Location: Golden Valley, MN 55427 (Hybrid) (temp-to-hire)Duration: 12 Months Shift: M-F Job Title: Packaging Development ... Specialist - Integrated Project Solutions About the Role: This...collaborate with cross-functional teams (Marketing, Suppliers, Food Safety & Quality , and R&D) to launch new products and packaging… more
- Curia (Springfield, MO)
- …Specialist III primarily works in the cGMP areas to manage adherence to the quality system and initiate the resolution of deviations. To perform this job ... of personnel in full accordance with cGMPs and Curia's quality system to ensure real-time compliance +...compilation, systems and controls to ensure inspection-ready quality systems (ISO, FDA, QP, EMEA) for… more
- Merck & Co. (Rahway, NJ)
- …by providing timely/accurate responses to questions and/or observations.-- Facilitate equipment/ system changes, execute periodic reviews and support Quality ... Operations, Process Engineering, Process Optimization, Product Formulation, Protocol Development, Quality Management, Regulatory Inspections, Reliability Management, SAP… more
- Aequor (Framingham, MA)
- Mon-Fri 800-430 EST The Third Party Management Specialist will oversee Third Party Quality operations for the MA BioCampus, ensuring excellence in quality ... cGMP manufacturing environment within an FDA-regulated industry, proficiency in Veeva quality management systems , and strong knowledge of global pharmaceutical… more
- Cipla (Fall River, MA)
- …experience writing, revising, and creating cGMP records and SOP's. Experience with quality system compliance. Ability to work effectively both independently and ... Job TitleMDI Operations Specialist Organization NameInvaGen Pharmaceuticals, Inc. LocationFall River location Employment TypeFull Time ShiftSecond Shift Salary Range… more
- Terumo Medical Corporation (Somerset, NJ)
- …applicable regulatory requirements, while driving continuous improvement in clinical quality systems and processes. Key responsibilities include planning and ... Sr. Clinical Quality Specialist Date: Nov 19, 2025...is comprised of two strategic business divisions: Terumo Interventional Systems and Terumo Medical Products. We believe that the… more
- Arvato Bertelsmann (Louisville, KY)
- …safe, timely, and effective implementation. * Assist in the development/enforcement of the quality systems within all departments (at all levels) by ensuring the ... in the preparation of the surveillance of 3rd party quality systems audits to maintain certifications. *...* Assist in the development of Turtle Diagrams, Management System requirements, and potential changes to regulatory … more
- Merck & Co. (Rahway, NJ)
- …clinical supplies. Interacts with key partner organizations such as clinical development, regulatory , quality and other supply chain areas to address clinical ... partners and senior leaders. Works directly in the SAP system to establish a consolidated, visible forecast for all...for assigned studies. Utilization of key technological tools and systems for GCS planning such as SWMS, Veeva, MEDS,… more
- GRAIL (Durham, NC)
- …planning process. + Maintain and improve these programs in compliance with GRAIL's Quality Management System procedures and regulatory requirements including ... the Senior Director, Quality Strategy & Operational Excellence, the Senior Quality Specialist is responsible for executing, maintaining, and improving key … more
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