- 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
- Actalent (Fort Lauderdale, FL)
- …HPLC, UPLC, and UV-Vis techniques. + Strong analytical chemistry. + Familiarity with FDA and GMP regulations. + Ability to analyze and interpret complex data. ... laboratories. Work Environment This position is based in a lab environment regulated by FDA and GMP standards. The work schedule is 2nd shift from 2pm-11pm, with all… more
- embecta (Parsippany, NJ)
- …knowledge in the area of customer relations, PMS, complaint trending, MDR submissions, FDA regulations, GMP and clinical laboratory functions. + Knowledge of US and ... regulations and standards that apply to the medical device industry including FDA Quality Systems Regulations, ISO 13485, ISO 14971, EU MDR, Canadian MDR,… more
- Actalent (Springfield, MO)
- …organisms. + Familiarity with ISO accreditation and regulatory requirements ( FDA , USDA, AOAC methods). + Excellent leadership, communication, and organizational ... technical issues and implement corrective actions. + Maintain compliance with ISO/IEC, FDA , USDA, and other relevant regulatory standards. + Oversee internal audits,… more
- Actalent (Minneapolis, MN)
- …and suppliers. + Ensure compliance with design controls, international standards, and FDA guidelines. + Implement product stability program. + Adhere to ethical ... controls, risk management, statistics, and development processes. + Familiarity with FDA , QSR, and ISO requirements. + Problem-solving capabilities. Job Type &… more
- Aspirus Ironwood Hospital (Wausau, WI)
- …ARRT (American Registry of Radiologic Technologists) certification requirements. + Meets FDA Mammography Quality Standards Act (MQSA) mandated requirements. + A ... may be under physical and/or emotional stress. + Meets and maintains the FDA Mammography Quality Standards Act (MQSA) requirements. + Analytical skills are necessary… more
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