- Actalent (Maple Grove, MN)
- …3 to 5 years in Quality. + Deep understanding of CE Marking, EU MDR, FDA Medical Device Regulation (MDR), and FDA requirements. + Extensive knowledge of ... manufacturing processes and practices relevant to the company's products. + Proficiency in Microsoft Office applications including Excel, Word, and Outlook. + Ability to work collaboratively across all organizational levels. + Strong leadership skills to… more
- Actalent (Minneapolis, MN)
- …programmatic risks. + Support regulatory milestones by ensuring project deliverables meet FDA , EU MDR, and IEC expectations. + Lead communication and coordination ... circuitry, and distal assembly design considerations. + Experience with FDA submission support, verification/validation planning, and clinical build coordination.… more
- Actalent (Menomonee Falls, WI)
- …You'll design and implement comprehensive safety programs that meet OSHA, FDA , and pharmaceutical industry standards, ensuring compliance and protecting our ... & Implement Safety Programs: Create site-specific safety plans aligned with OSHA, FDA , and pharmaceutical standards. + Risk Assessment: Identify hazards related to… more
- Charles River Laboratories (Rockville, MD)
- …+ Excellent working knowledge and experience with the practical implementation of FDA , EMA and ICH regulations and guidelines + Experience in TrackWise is ... worked on 80% of the drugs approved by the US Food and Drug Administration ( FDA ) in the past five years. We're committed to providing benefits that elevate your… more
- Aerotek (Smyrna, TN)
- …proficiency in MS Office. + Minimum 5 years of related manufacturing experience in an FDA facility preferred. + 3 years of experience in a non- FDA facility is ... considered average. + Previous experience in GMP or Food Manufacturing is a plus. **Why Work Here?** Join a stable company offering great benefits, including an ESOP program. Enjoy working with a team committed to continuous improvement in a supportive and… more
- Northwell Health (Westbury, NY)
- …inspections and submissions. 9.Provides guidance on regulatory submissions to the FDA which may include an Investigational New Drug (IND), Investigational Device ... New Drug Application (NDA) or other research under the purview of the FDA . 10.Prepares and forwarding monitoring reports to program manager. Working with study staff… more
- Colgate-Palmolive (Hodges, SC)
- …asset utilization and operational efficiency while ensuring strict adherence to GMP, FDA quality and safety standards. You will implement the standards of Factory, ... Tools (eg Lean six sigma, Reliability) + Experience in regulated facilities ( FDA ) **Compensation and Benefits** Salary Range $79,200.00 - $131,250.00 USD Pay is… more
- Aerotek (Bethlehem, PA)
- …correctly. Your attention to detail is essential as you will be dealing with FDA -regulated products, with a focus on quality over quantity. You will work a rotating ... + Experience operating stand-up forklifts. + Attention to detail and adherence to FDA regulations. + Ability to identify errors and ensure compliance with GMP/SOPs.… more
- Lilly (IN)
- …in compliance with current local and international regulations, laws, guidance (eg FDA , ICH, and CPMP etc.), Good Clinical Practices (GCPs), company standards, Lilly ... the medical sections of the IND and Investigator Brochure, preparation of FDA advisory committee regulatory hearings and label discussions, and communications and… more
- Actalent (Lawrence, IL)
- …with aluminum foil and other unsupported structures. + Knowledge of FDA -approved inks and coating technologies. + Understanding of rotogravure and flexographic ... Pharmaceutical, and more. The facility supports technologies and processes like FDA -approved inks, rotogravure, and flexographic printing, along with adhesive and… more
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