- Merck & Co. (North Wales, PA)
- … Review (OPAR)The Associate Director is responsible for the review and approval of all US promotional materials and serving as the promotional regulatory ... objectives.Serve as the liaison and manages correspondence with FDA's promotional review divisions Office of Promotion and Advertising Review (OPDP)/Advertising… more
- Merck & Co. (Durham, NC)
- Job DescriptionSenior Specialist, Quality Systems and Compliance (P3) Our company is expanding its global recombinant vaccine production network by investing and ... for daily support and oversight of all production processes to ensure compliance with regulatory requirements as well as policies and procedures.- Responsible for… more
- Aequor (West Greenwich, RI)
- …procedures and products follow cGMP practices and other applicable regulations. Performs review and approval of cGMP processes, procedures, documents and ... to written procedures and cGMP requirements. Alert management of quality, compliance , supply and safety risks. Complete required assigned training to permit… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …may include review of vendors agreements and policies, external training materials (eg, CRO training materials ), study protocols, subject recruitment ... and/or compounds, including providing legal guidance memos, both independently and for review , approval , and use by management and/or business customers.… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …as contracts, correspondence (eg, to regulatory agencies), both independently and for review , approval , and use by Legal Affairs management. Independently ... manager of the role.]- Creates, implements, and presents training programs and materials on legal issues for various departments. Monitors current developments in… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …organization in its build and ramp-up of clinical production and facility approval of a state-of-the-art cell therapy facility for commercial launch and sustained ... as SME on engineering design projects; sets project requirements, evaluates compliance with project and engineering standards, and approves final designs and… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …change management procedures, including business engagement, impact analysis, documentation review and approval , user testing reviews, ensuring smooth ... Master Data Governance Sr. Specialist with a specific focus on Materials orchestration throughout the End-to-End Manufacturing & Supply lifecycle. This role… more
- Aequor (West Greenwich, RI)
- …procedures and products follow cGMP practices and other applicable regulations. Performs review and approval of cGMP processes, procedures, documents and ... to written procedures and cGMP requirements. Alert management of quality, compliance , supply and safety risks. Complete required assigned training to permit… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- … compliance , oversight to the field-based Medical Liaison group; and medical review of promotional materials , grants, and publications. This position will own ... to support our products. Provide strategic input into the development and approval of Phase IIIb/IV trials in collaboration with global internal stakeholders.… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …and/or CAPAs.Represent and support Regulatory Inspections for QC.Perform peer review / approval of laboratory data.Utilize electronic systems (LIMS) for ... in a controlled cGMP cleanroom environment.Ensure testing is completed in compliance with all applicable procedures, standards and GMP regulations.Work with Process… more
- Heritage Environmental Services, LLC (Benton, AR)
- …within limits of permits, operations, business rules. + Maintain DEA program. + Review profiles for compliance with WAP and acceptability into internal ... IC pricing. + Manage conditional approvals. + High hazard review calls with generators. + Assign PPE. + Enforce...operations. + Coordinate with plant and corporate safety and compliance . + Seek 3rd party outlets for materials… more
- Lilly (Durham, NC)
- …product/process development, change controls) as material quality SME + Be able to perform materials SAP data steward functions + Review and Redline Materials ... make life better for people around the world. The Quality Assurance Associate for Materials Management is responsible for the site parenteral & device materials … more
- J&J Family of Companies (Spring House, PA)
- …for leading all aspects of and ensuring the successful implementation of the Compliance Review Committee (CRC) process. This role works closely with the ... and retention purposes are compliant and undergo the vital compliance review process. **Principal Responsibilities:** + Lead...generate alternate recommendations on content. + Accountable for the review and approval of all recruitment and… more
- Catalent Pharma Solutions (Baltimore, MD)
- …to template requirements and information provided by technical groups; adjust the materials specification templates as needed to assure compliance with ... **Specialist, QA - Raw Materials ** **Position Summary** Catalent is a global, high-growth,...regulations and client expectations. + Routes specifications for review and approval through workflow in the… more
- Fujifilm (Holly Springs, NC)
- …North Carolina, United States. **External US** **About This Role** The QC Raw Materials (RM) Scientist 1 will be responsible for participating in the Technology ... with limited supervision. This includes onboarding of new and generic raw materials as part of new customers/programs. Providing assessments, QC raw materials… more
- Lilly (Indianapolis, IN)
- …perform materials LMS data steward functions, if necessary. + Review and Redline GMP documents, including specifications and procedures. Provide procedure ... the world. Position Description: To provide support to the Parenteral Products materials management systems. The Parenteral Materials Management team provides… more
- Montana Tech (Butte, MT)
- Assistant Professor- Metallurgical & Materials Engineering Montana Technological University provides a comprehensive benefits package for all eligible positions that ... program. Applications received by October 1, 2024 will be guaranteed full review and consideration. Applications received after that date may be considered until… more
- State of Massachusetts (Hopkinton, MA)
- …Department of MassDOT is responsible for the testing of products, and the verification, approval and acceptance of materials , to assure that materials ... compliance to ensure construction safety. * Testing of materials such as: concrete cylinders, concrete beams, fence items,...review in order to determine if your submitted materials meet the minimum entrance requirements for the position.… more
- Herbalife (Winston Salem, NC)
- Site Buyer/ Materials Planner Category: Supply Chain Position Type: Regular Full-Time External ID: 14827 Location: Winston-Salem, NC, United States Date Posted: Sep ... on LinkedIn share to linkedin Apply Now **Overview** **THE ROLE:** The Site Buyer/ Materials Planner will lead and support management to ensure that Raw Materials… more
- Lilly (Pleasant Prairie, WI)
- …+ Provide input, guidance and recommendation for Supplier / Service Provider approval and certification activities. + Responsible for materials and supplier ... global. + Conduct material and supplier risk assessments and classifications for materials and supply chain participants where required. + Formally approve or reject… more
