- Novo Nordisk Inc. (Plainsboro, NJ)
- About the Department The Clinical, Medical and Regulatory (CMR) department at Novo Nordisk is one of the most diverse and collaborative groups within the ... organization. From health-care-provider interactions and developing and implementing regulatory strategies with the FDA to providing medical education and collecting… more
- Merck & Co. (Rahway, NJ)
- …and other applicable worldwide regulations and our Company procedures.- The Senior Specialist will become knowledgeable in regulatory requirements, cGMPs and our ... Job Description Job Description: The Rahway based Senior Specialist , Global Development Quality Operations - API, is responsible for independent review and approval… more
- Merck & Co. (Durham, NC)
- Job DescriptionWe are seeking a Growth and Improvement minded Specialist , Sterility Assurance that can help drive our Strategic Operating Priorities.Invent - Pursue ... and Standards will Continue to Guide Us as We Take on New ChallengesThe Specialist , Sterility Assurance will serve as a member of the Sterility Assurance team… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionThe Global Clinical Data Standards Vocabulary Specialist , Associate Director, is a subject matter expert in CDISC Controlled Terminology and applying ... with Health Authority regulations and guidance and company best practices.The Vocabulary Specialist is able to:Work independently, collaboratively as a member of a… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionQuality Assurance Specialist (Hybrid) The mission of Quality Assurance is to safeguard the rights and well-being of patients; comply with applicable ... global regulatory requirements through sound processes and procedures, and to...with current Good Manufacturing Practices (GMP) regulations and relevant regulatory filing submissions. Areas of focus of this position… 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
- Legend Biotech USA, Inc. (Iowa City, IA)
- …in the treatment of multiple myeloma.Legend Biotech is seeking Senior Cell Therapy Account Specialist as part of the Commercial team based Remote / Field based in ... Iowa and Nebraska. Role OverviewThe Cell Therapy Account Specialist is responsible for representing Legend's products and services to a defined customer base,… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …immunotherapy in the treatment of multiple myeloma.Legend Biotech is seeking a Maintenance Specialist I (3rd shift) as part of the Facilities & Engineering team ... thermal energy principals, mechanical maintenance techniques, and electromechanical theoryEnsures regulatory and job training remains current by promptly completing… more
- Novo Nordisk Inc. (West Lebanon, IN)
- …Reviews and assesses Corrective and Preventive Action Reports Participates in Regulatory Inspections Other duties as assigned Performs all job duties and ... biologic facility regulated by the FDA, EMEA or a leading international regulatory agency preferred As applicable, experience with Quality Assurance oversight and… more
- Merck & Co. (South San Francisco, CA)
- …and related documents, managing author/management reviews, ensuring documents meet regulatory compliance requirements, and ensuring documents and document packages ... in Microsoft Office and GraphPad PrismA good understanding of the content of regulatory filings for nonclinical pharmacology in the context of CTD, IND, IMPD,… more
- Novo Nordisk Inc. (West Lebanon, IN)
- …performing 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… more
- Ochsner Health System (Chalmette, LA)
- …Completes timely quality control procedures in accordance with regulatory standards and performing notification/remediation as warranted. Leads departmental ... knowledgeable on current federal, state and local laws, accreditation standards or regulatory agency requirements that apply to the assigned area of responsibility… more
- Ochsner Health System (Scott, LA)
- …Completes timely quality control procedures in accordance with regulatory standards and performing notification/remediation as warranted. Leads departmental ... knowledgeable on current federal, state and local laws, accreditation standards or regulatory agency requirements that apply to the assigned area of responsibility… more
- Ochsner Health System (Luling, LA)
- …knowledgeable on current federal, state and local laws, accreditation standards or regulatory agency requirements that apply to the assigned area of responsibility ... and ensures compliance with all such laws, regulations and standards. This employer maintains and complies with its Compliance & Privacy Program and Standards of Conduct, including the immediate reporting of any known or suspected unethical or questionable… more
- Merck & Co. (Durham, NC)
- Job DescriptionSenior Specialist , Quality Systems and ComplianceOur company is expanding its global recombinant vaccine production network by investing and adding a ... comprised of fermentation, microfiltration/ultrafiltration, and chromatography steps.The Quality Senior Specialist provides expertise in the coordination of resources and… more
- Aequor (Libertyville, IL)
- …investigations and initiating deviations and Change Control activities.Working knowledge of regulatory requirements and how they relate to existing and new business ... PURPOSE AND SCOPE OF POSITION:The Manufacturing IT Systems Quality & Compliance Specialist - Cell Therapy Manufacturing Systems supports the successful operation of… more
- Merck & Co. (Durham, NC)
- Job Description Job Description: We have an exciting opportunity for an Associate Specialist to join the technical operations team for our company Teknika in Durham, ... lyophilization, product inspection, and quality control laboratories. - The Specialist , Technical Operations engineer is responsible for providing technical support… more
- Merck & Co. (Durham, NC)
- Job DescriptionPosition Description: Senior Specialist , Quality Assurance Our Company will construct a new manufacturing facility to significantly expand its ... product inspection, and quality control laboratories.The Senior Quality Assurance Specialist will support this expansion. Project activities requiring support… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …the Manufacturing Excellence team as a technical individual contributor by providing specialist knowledge and expertise of cell and gene therapy processes and/or ... change controls and maintain permanent inspection readiness and actively support regulatory inspections. This individual will also support the implementation of… more
- Merck & Co. (Durham, NC)
- …with our incredibly high standards of quality and meets all regulatory requirements.- Partnering across our internal manufacturing facilities, external contract ... on time, every time, across the globe. The main function of the Associate Specialist , Quality Control is to assist in the assurance of the quality of product… more
Related Job Searches:
Principal Regulatory Affairs Specialist,
Regulatory,
Regulatory Affairs Specialist,
Regulatory Affairs Specialist II,
Regulatory Compliance Specialist,
Senior Regulatory Affairs Specialist,
Senior Regulatory Specialist,
Specialist,
Sr Regulatory Affairs Specialist,
Staff Regulatory Affairs Specialist