- Endo International (Rochester, MI)
- …Laboratory Practices (GLP) and Good Manufacturing Practices (GMP) + Ensure compliance with FDA and other regulatory standards + Follow safety procedures and ... 4,000+ team members worldwide, we lead with pride and purpose-prioritizing quality and safety while fostering a culture of continuous improvement, accountability,… more
- VTI Life Sciences (San Diego, CA)
- …those systems used in regulated environments are validated in compliance with industry standards, regulatory requirements (such as FDA 21 CFR Part 11 and 820, ... and preliminary problem diagnosis. + Provide all services in accordance with FDA cGxP guidelines and regulations. QUALIFICATIONS: + Bachelor's degree or higher in… more
- Bristol Myers Squibb (Princeton, NJ)
- …and troubleshooting. + Drive proactive risk identification, mitigations, and CAPA implementation. Quality Management Systems + Ensure adherence to FDA 21 CFR ... cytometry as valuable complements. You will ensure compliance with FDA 21 CFR Part 820, IVDR, CLIA, CAP, ISO13485,...LIMS, ELN, and clinical data management systems to support regulatory submissions and study execution. Project & CRO Management… more
- Takeda Pharmaceuticals (Los Angeles, CA)
- …applicable QC Microbiology Standard Operating Procedures (SOP) to ensure compliance with FDA guidelines, QSR, cGMP, and other regulatory standards and drive ... procedural improvements. + Support internal and external audits (eg, FDA , Corporate Quality Assessments) by ensuring compliance with procedures, guidelines, and … more
- J&J Family of Companies (Danvers, MA)
- …comply with EHS standards and device safety requirements. + Maintain alignment with regulatory expectations (eg, FDA QSR/21 CFR Part 820, ISO 13485) and ... quality , cost, and schedule. + **Cross-Functional Collaboration** + Partner with Quality , Regulatory , Supply Chain, Manufacturing, and R&D to align on… more
- University of Rochester (Rochester, NY)
- …accurate and complete source documentation in accordance with GCP and federal regulations ( FDA , NIH, OHRP) + Perform quality assurance reviews to ensure ... & Documentation - 15% + Source documentation, AE/SAE reporting, audit preparation, and regulatory submissions. Study Coordination & Quality Improvement - 10% +… more
- BeOne Medicines (Pennington, NJ)
- …and release of material, intermediates and finished products under FDA /EU regulations, applicable International Regulations, BeOne processes and procedures. ... Establishes and implements QC Biochemistry procedures and supports regulatory compliance inspections. Ensures efficient and effective day to day operations of the… more
- Insight Global (Lincolnshire, IL)
- …documentation for Corporate Systems & Innovation to meet and maintain internal RA/QA and FDA requirements and will be a key participant as needed in external audits, ... including those performed by the FDA . Essential Duties and Responsibilities: 1. Responsible to provide consultation services to leadership on design/development,… more
- Xeris Pharmaceuticals, Inc. (Chicago, IL)
- …etc.). + Ensure accuracy, clarity, consistency, and compliancewith internal standards, applicable regulatory guidelines (eg, ICH, FDA , EMA), and company SOPs. + ... editing and content review. + Ensures document content and style adheres to FDA /EMA or other appropriate regulatory guidelines and complies with departmental… more
- Covenant Health Inc. (Knoxville, TN)
- …other accreditation as required or requested. Adhere to established FDA regulatory requirements. Maintain and document all required quality control measures ... from radiologists/physicians/surgeons, other health care professionals as well as ACR / FDA /other. Initiates and maintains Breast Center Program development . +… more
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