- Good Sense Foods (New Hope, MN)
- …standards. This role leads the sanitation team, monitors work, ensures compliance with regulatory guidelines ( FDA , USDA, SQF, etc.), and works closely with ... production and quality assurance teams to maintain a safe, clean, and...ensure compliance with all Good Manufacturing Practices (GMPs), HACCP, FDA , USDA, and BRC standards. * Maintain accurate sanitation… more
- Takeda Pharmaceuticals (Social Circle, GA)
- …requirements. You will work in close cooperation with the manufacturing departments, Engineering, Regulatory , QC, and Quality Operations on a daily basis. **How ... applicable. + Participate and work with project team members (Engineering, Manufacturing, Regulatory Affairs, Quality Operations, Quality Validation, Supply… more
- WuXi AppTec (Middletown, DE)
- …stability program timelines. Regulatory Compliance * Ensure all analytical testing meets FDA , EMA, and ICH regulatory requirements for drug product QC. * ... testing for finished dosage forms. * Strong understanding of ICH, USP, EP, JP, FDA , and EMA regulatory requirements for drug product QC. * Demonstrated ability… more
- WuXi AppTec (Middletown, DE)
- …stability program timelines. Regulatory Compliance * Ensure all analytical testing meets FDA , EMA, and ICH regulatory requirements for drug product QC. * ... forms. * Strong understanding of ICH, USP <61>, <62>, <85>, <1116>, EP, JP, FDA , and EMA regulatory requirements for drug product QC. * Demonstrated ability… more
- System One (Diamondhead, MS)
- …ensures that all study activities are performed in compliance with ICH-GCP, FDA , and institutional standards, prioritizing participant safety, data integrity, and ... regulatory compliance. The PI serves as the main point...Sub-Investigator in clinical research. + Strong understanding of ICH-GCP, FDA regulations, and clinical research ethics. + Proven leadership… more
- Stanford University (Stanford, CA)
- …clinical research staff and management of clinical research operations, including quality management, personnel management, regulatory compliance, and fiscal ... for multiple studies. Complete annual reports to Institutional Review Board, CSTA, FDA and other regulatory agencies. Submit Investigational New Drug… more
- J&J Family of Companies (Raritan, NJ)
- … regulatory standards, and environmental controls to safeguard product quality , safety, and operational efficiency. **Key Responsibilities:** + Participate in the ... that is positively impacting patients' lives by ensuring high quality and reliable supply of our cell therapy products?...activities related to HVAC components, ensuring compliance with EMA, FDA , and other regulatory standards. + Provide… more
- United Therapeutics (Morrisville, NC)
- …Document all laboratory activities in compliance with GLP, CLIA, CAP, EFI, and/or FDA regulatory requirements + Assist in writing, reviewing, and updating SOPs, ... pulmonary arterial hypertension ( **PAH** ). Today, we have six FDA -approved therapies that treat PAH, pulmonary hypertension associated with interstitial lung… more
- Kelly Services (Burlington, NJ)
- …from the ground up, and ensure adherence to FDA and other regulatory frameworks. You'll collaborate closely with Quality Assurance, Quality Control, ... with stakeholders during strategic planning. + Lead notifications regarding regulatory changes affecting operations. + Oversee responses and communication with… more
- Koniag Government Services (Silver Spring, MD)
- …a Scientific Subject Matter Expert I to support our data abstraction and quality control processes for regulatory applications and scientific reports. This ... leveraging their subject matter expertise to abstract data from regulatory applications and complex scientific reports accurately. The primary responsibilities… more