- Cedars-Sinai (Los Angeles, CA)
- …and work with bioinformatics to develop and maintain trial management systems. Ensures compliance with all federal and local agencies including the Food and Drug ... Administration ( FDA ) and local Institutional Review Board. **Primary Duties and...May train clinical research staff to help improve the quality of the data being collected. + May solve… more
- BeOne Medicines (San Mateo, CA)
- …authorities to deal with Logistics issues as needed, for example, Customs and FDA . + Coordinate internal or external functions for the Import and export permit ... VAT refund as needed. + Perform all responsibilities in compliance with internal procedures and external regulations related to...in logistics audits as needed. + Support SCL on FDA inspection, internal audit and external audit as needed… more
- Abbott (Columbus, OH)
- …general housekeeping and sanitation tasks. + You'll be accountable for meeting our compliance standards including FDA , OSHA and Abbott policies and procedures. ... part of a family that works together to produce quality products that make a difference and help keep...FDA regulated manufacturing environment Apply Now (https://www.jobs.abbott/us/en) In compliance with federal law, all persons hired will be… more
- Lilly (Indianapolis, IN)
- …Activities** : FAT, commissioning, and validation of equipment and workflows. + ** Compliance ** : Ensure that all systems and equipment meet **GMP and regulatory ... standards** ( FDA , EMA, etc.) from design through validation + **Support...production. + **Collaborate** with cross-functional teams including Engineering, TSMS, Quality , and operations to support CQV/PE deliverables. + Translate… more
- Catalent Pharma Solutions (Chelsea, MA)
- …needs.** **Catalent is committed to a Patient First culture through excellence in quality and compliance , and to the safety of every patient, consumer, ... Part11 assessments and GMP evaluations of control systems to ensure they meet FDA requirements + Prepares standard operating procedures for new and existing control… more
- US Tech Solutions (New Albany, OH)
- …in the coordination of tech support on engineering, regulatory, compliance , calibration, quality , microbial/environmental, technical cleaning, validation, ... calibration/electrical systems and technical cleaning systems are maintained in compliance with all applicable industry standards, regulatory standards and … more
- Terumo Neuro (Aliso Viejo, CA)
- …for worldwide product approval submission activities focused on US/EU/Canada and ensuring compliance to FDA and international regulatory agency requirements for ... per MicroVention procedures. + Review promotional material and labeling for regulatory compliance as assigned. + Develop and maintain regulatory files and records. +… more
- Aerotek (Camarillo, CA)
- …secure, and label containers according to company and customer specifications while ensuring compliance with GMPs, SOPs, FDA , and DEA requirements throughout the ... and SOPs. + Fill, secure, and label containers as per specifications. + Ensure compliance with GMPs, SOPs, FDA , and DEA requirements. + Use computers to… more
- CSL Behring (King Of Prussia, PA)
- …Support the development and maintenance of PV systems and processes in compliance with international standards (ICH, EMA, FDA ). * **Cross-functional ... Collaboration** Liaise with GRAS, clinical, medical affairs, and quality assurance teams to ensure alignment on compliance and safety strategies. Participate in… more
- University of Colorado (Aurora, CO)
- …Maintain detailed records of studies including Patient Source Document Binder to ensure compliance with requirements of the Food and Drug Administration ( FDA ), ... Assists with Sponsor, Data Safety Monitoring, and Food and Drug Administration ( FDA ) audits and responses + Participate in subject recruitment efforts, including… more