- 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 ... is maintained across all systems and processes, supporting product quality , patient safety, and regulatory compliance This...program and supervise CSV associates. Ensure compliance with cGMP, FDA , EMA (Annex 1), and other global regulatory… more
- Actalent (St. Louis, MO)
- …plays a critical role in ensuring that all products meet company and regulatory standards for safety, quality , and consistency. This position involves monitoring ... Quality Technician Job Description We are seeking a...microbiological and chemical testing. + Verify compliance with HACCP, FDA , USDA, and other regulatory requirements. +… more
- Medtronic (Fridley, MN)
- …to Have (** **Preferred Qualifications** **)** + Strong understanding of global regulatory requirements for medical devices, including FDA regulations (eg, 21CFR ... extraordinary. **Careers That Change Lives** In this exciting role as the **Senior Quality Systems Program Manager** , you will lead strategic initiatives to improve… more
- Actalent (Hercules, CA)
- …accurate and complete test records and complete assigned CAPAs, change controls, and quality plans. + Stay current with regulatory and industry standards, ... Job Title: Quality Assurance Review Specialist IJob Description The ...accordance with SOPs, cGMP, cGLP, ISO/IEC, and other applicable regulatory requirements. + Coordinate thorough data review of results… more
- Abbott (Alameda, CA)
- …to identify, review and assess the impact of worldwide product manufacturing, quality , regulatory or safety issues that arise in complaint investigations, ... medicines. Our 114,000 colleagues serve people in more than 160 countries. **Product Quality Assurance Analyst II** **Working at Abbott** At Abbott, you can do work… more
- Vantage Specialty Chemicals (Englewood, OH)
- …compliance with ** FDA , GMP, ISO, HACCP** , and other applicable regulatory and quality standards. **Education & Experience** + **Education:** List minimum ... manufacturing and packaging procedures, validating processes, and ensuring compliance with regulatory and quality standards. The role involves hands-on work… more
- Otsuka America Pharmaceutical Inc. (Salem, OR)
- …planning of regulatory interactions and Provides tables and listings for FDA meeting briefing packages. + Support statistical needs for market access and ... statistical expertise/input in the drug development including clinical development plan and regulatory submission strategy. This is a strategic and critical role in… more
- Boehringer Ingelheim (Ridgefield, CT)
- …+ Influences critical labeling operational activities as appropriate to successfully generate quality documents with internal customers and with FDA to achieve ... Submissions to FDA - + Prepares labeling documents needed for regulatory submissions with contributing functions in other departments such as RA Product Labeling… more
- Hologic (San Diego, CA)
- …architecture diagrams. + Collaborate with cross-functional teams (Product Engineering, DevSecOps, Regulatory , Quality ) to integrate security into the product ... Hologic products, and manage these risks according to established quality procedures. + Participate in continuous improvement of our... FDA submissions. + Maintain current knowledge of FDA and other regulatory body's cybersecurity guidance… more
- Stryker (Irvine, CA)
- …maintaining regulatory excellence. + **Partner** with cross-functional teams (R&D, Regulatory , Operations, Quality , and Marketing) to align on change ... - Inari Medical is seeking a strategic **Senior Manager, Quality Management Systems** in **Irvine, CA!** In this onsite...+ Strong knowledge of QMS regulations and standards (eg, FDA CFR, ISO 13485, MDSAP, EU MDR). + Experience… more