- Merck & Co. (Durham, NC)
- …team is seeking a highly motivated individual to serve as a Senior Operations Specialist within the Operations Manufacturing Support team. -In this role, you must be ... Collaborates with Operations, Technology and Quality to author regulatory inspection observation responses and completes remediation projects, as required. Assists… more
- Aequor (Oceanside, CA)
- Job Title : Document Specialist Location : Oceanside, CA 92056 Duration : Until 09/05/2025 Job Summary: Responsible for owning and overseeing all Site Operations ... documents through creation and revision, the Site Operations Documentation Specialist helps to define and adhere to documentation guidelines by managing document… more
- Aequor (Devers, TX)
- …InspectionsEHS program implementationPosition: Environmental, Health, and Safety Senior Specialist (EHS Senior Specialist )Location: Onsite role-Local candidates ... local levels. The position will also involve participation in self-assessments, inspections , GEMBAs, hazard assessments, and audits. Overall, this position plays a… more
- Novo Nordisk Inc. (West Lebanon, IN)
- …accountability. This role requires prior CAD experience as they will support the CAD Specialist with CAD drawings as needed. The Engineering Area Data Specialist ... holders. Retrieves and presents relevant Engineering Data during audits and inspections Proposes and implements enhancements that will improve the performance and… more
- Merck & Co. (Durham, NC)
- …includes facility start up, licensure, and ramp up to full production.As a Senior Specialist , Operations you will be in a critical position to the organization with ... looking to build or expand your career in Vaccine Manufacturing. As a Senior Specialist you will be given the opportunity to challenge and grow your talents through… more
- Novo Nordisk Inc. (West Lebanon, IN)
- …and reporting internal and vendor audits as scheduled Participate in Regulatory Inspections Performs all job duties and responsibilities in a compliant and ethical ... manner and in accordance with all applicable healthcare laws, regulations and industry codes Incorporates the Novo Nordisk Way and 10 Essentials in all activities and interactions with others Other duties as assigned Physical Requirements While performing this… more
- Novo Nordisk Inc. (West Lebanon, IN)
- …and assesses Corrective and Preventive Action Reports Participates in Regulatory Inspections Other duties as assigned Performs all job duties and responsibilities ... in a compliant and ethical manner and in accordance with all applicable healthcare laws, regulations and industry codes Incorporates the Novo Nordisk Way and 10 Essentials in all activities and interactions with others Physical Requirements Local and… more
- Aequor (Framingham, MA)
- …a culture of continuous compliance. Perform batch record review. Perform quality inspections of intermediates and finished goods. Perform review of QC data. Perform ... operations Conduct review of testing results. Review document and complete inspection of returned goods. May be involved with establishing compliance requirements… more
- Aequor (Northborough, MA)
- …as well as assist and participate in external audits and regulatory inspections Interpreting complex, explicit documentation for new and current procedures and FDA ... enforcement actions/trends Completing analysis, identifying issues and providing recommendations for compliance improvements Completing Quality Events in Veeva Development and training of new staff as needed Participate in specialized projects both within… more
- Novo Nordisk Inc. (West Lebanon, IN)
- …supervision Understanding/application of quality systems Support of Health Authority inspections Possesses technical and systems knowledge and can research ... information outside of knowledge base May need to support hands-on manufacturing within the given area for production coverage Has ability to recognize problems and recommend solutions to problems based on technical understanding of the process and equipment… more
