- Herbalife (Winston Salem, NC)
- …+ High school diploma or GED equivalent. **PREFERRED QUALIFICATIONS:** + Food and Drug Administration ( FDA ) other regulatory . + Experience using high ... Speed Mixer, Dryers, Fitz mill, Sweco, scales and tablet presses. + Current Good Manufacturing Practices (CGMPS). At Herbalife, we value doing what's right. We are proud to be an equal opportunity employer, making decisions without regard to race, color,… more
- Herbalife (Winston Salem, NC)
- …degree in Automation/Electronics or Industrial Maintenance Technology/Mechatronics * Food and Drug Administration ( FDA ) or other regulatory experience ... * 5+ years of work experience in a high-speed manufacturing environment * Food manufacturing or packaging experience, and/or blending equipment, batching operation systems **PHYSICAL DEMANDS:** In general, the following physical demands are representative of… more
- Herbalife (Winston Salem, NC)
- …degree in Automation/Electronics or Industrial Maintenance Technology/Mechatronics * Food and Drug Administration ( FDA ) or other regulatory experience ... * 5+ years of work experience in a high-speed manufacturing environment * Food manufacturing or packaging experience, and/or blending equipment, batching operation systems **PHYSICAL DEMANDS:** In general, the following physical demands are representative of… more
- Herbalife (Winston Salem, NC)
- …protocols. * Knowledge of safety PLCs and machine safeguarding standards. * Food and Drug Administration ( FDA ) or other regulatory experience * Work ... experience in a high-speed manufacturing environment (manufacturing or packaging experience, and/or blending equipment, batching operation systems). **PHYSICAL DEMANDS:** In general, the following physical demands are representative of those that must be met… more
- University of Washington (Seattle, WA)
- …complex programs, activities, or units. - Thorough knowledge of IACUC, IRB, HIPAA, and FDA regulatory requirements for the conduct of research. - Excellent oral ... FDA , sponsor, and Institutional Review Boards). Serve as divisional resource for FDA Investigational New Drug applications and communication. + Develop and… more
- System One (East Windsor, NJ)
- …position is responsible for creating a QA system to notify the US Food and Drug Administration ( FDA ) of illegitimate products, as and when needed. + This ... also review all finished product batches for compliance with applicable regulatory requirements and current Good Manufacturing Practice (cGMP) standards prior to… more
- Dr. Reddy's Laboratories (Princeton, NJ)
- …with US pharmacovigilance regulatory norm + Anchor drug safety regulatory inspection in US ( FDA regulatory agencies),participate in audits and ... identify and respond to signal analysis, and submit to regulatory agency ( FDA /Health Canada) within timelines to...medical Affairs and Medical Information activities. + Knowledge of FDA and Health Canada: Drug Discovery and… more
- Caris Life Sciences (Tempe, AZ)
- …and traceability. + Collaborate with Regulatory Affairs to prepare and review regulatory submissions (eg, FDA 510(k), PMA, EUA, IVDR), including pre- and ... Scientist plays a key role in bridging scientific insight and regulatory requirements for development of Next-generation sequencing (NGS) based in vitro… more
- Jabil (Hunt Valley, MD)
- …equipment, cleaning, computer systems and process in compliance with global regulatory requirements ( FDA , EMA, ICH, etc.)aseptic fill-finish environment and ... System Validation (CSV) program and supervise CSV associates. Ensure compliance with cGMP, FDA , EMA (Annex 1), and other global regulatory requirements for… more
- WuXi AppTec (Middletown, DE)
- …* Ensure QC laboratories, workflows, and processes meet cGMP requirements and global regulatory standards ( FDA , EMA, ICH, USP, EP, JP). * Coordinate QC ... lead all Quality Control functions for WuXi STA's new drug product manufacturing site, including QC Analytical, QC Microbiology,...site startup or major expansions. * Strong knowledge of FDA , EMA, and ICH guidelines and global regulatory… more