- Novo Nordisk Inc. (Plainsboro, NJ)
- …regulatory labeling-related activities. Updates internal processes to ensure compliance with health authority requirements and expectation Physical Requirements ... About the Department The Clinical, Medical and Regulatory (CMR) department at Novo Nordisk is one...ready to make a difference? The Position The Labeling Specialist supports the development of labeling activities for all… 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...(including new modalities such as ADCs) are manufactured in compliance with cGMP and regulatory filings. Perform… 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...batch documentation review ensuring our clinical supplies are in compliance with current Good Manufacturing Practices (GMP) regulations and… 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 ... associated reference data to data collection and transformation specifications in compliance with Health Authority regulations and guidance and company best… 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 ... to Guide Us as We Take on New ChallengesThe Specialist , Sterility Assurance will serve as a member of...understanding of the aseptic processes and controls to ensure compliance and provide Quality support to site projects. The… 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
- Novo Nordisk Inc. (West Lebanon, IN)
- …reviews of manufacturing and support documentation and records to certify compliance with in-house specifications/standards and GMP for all NNUSBPI products. This ... Essential Functions Reviews all manufacturing and support records to certify compliance with specifications and procedures Releases product based on Quality… 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 ... systemsPerform on-site equipment maintenance and critical utilities maintenance operations, and compliance . This includes but is not limited to: support to… more
- Novo Nordisk Inc. (West Lebanon, IN)
- …reviews of manufacturing and support documentation and records to certify compliance with in-house specifications/standards and GMP for all NNUSBPI products. This ... and reporting/trending Reviews manufacturing and support records to certify compliance with specifications and procedures Works closely with Manufacturing and… more
- Legend Biotech USA, Inc. (Iowa City, IA)
- …to healthcare professionals in accordance with Corporate, PhRMA, and OIG guidelinesStrict compliance with all regulatory agencies, state, and federal law is ... 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… 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 ... 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
- Merck & Co. (Durham, NC)
- …for daily support and oversight of all production processes to ensure compliance with regulatory requirements as well as policies and procedures.Responsible ... Job DescriptionSenior Specialist , Quality Systems and ComplianceOur company is expanding...participates in project suite teams, as required.Direct support of regulatory inspections and audits.Direct support of validation activities and… more
- Aequor (Libertyville, IL)
- …PI). PURPOSE AND SCOPE OF POSITION:The Manufacturing IT Systems Quality & Compliance Specialist - Cell Therapy Manufacturing Systems supports the successful ... Must have experience with IT Quality & Compliance applications and systems in a bio-tech manufacturing...and initiating deviations and Change Control activities.Working knowledge of regulatory requirements and how they relate to existing and… 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
- BioAgilytix (Durham, NC)
- …current compensation structure to introduce levels, job bands and gradesEnsure compliance with legal and regulatory requirements related to compensationOversee ... will include:Develop, review, and update total rewards policies and proceduresEnsure compliance with federal, state, and local regulations related to compensation… 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 ... across the globe. The main function of the Associate Specialist , Quality Control is to assist in the assurance...applicants with arrest and conviction records for employment in compliance with the San Francisco Fair Chance Ordinance Los… 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
