- Adecco US, Inc. (Monroe, NC)
- …development and process changes. . Serve as SME during internal audits and regulatory inspections ( FDA , ISO, Notified Bodies). . Maintain current knowledge of ... of sterilization modalities and microbiological testing methods. . Familiarity with ISO, FDA , and EU regulatory standards. . Excellent documentation, analytical,… more
- Endo International (Raleigh, NC)
- …and finished products to ensure they meet specifications.** + **Ensure adherence to FDA , EMA, and other regulatory standards, including PIC/S GMP requirements.** ... for overseeing all QC activities to ensure pharmaceutical products meet regulatory requirements and internal quality standards. This role involves managing QC… more
- Fujifilm (Raleigh, NC)
- …+ Comply with all applicable US Food and Drug Administration (US FDA ) medical device regulatory requirements, applicable ISO 13485 standard requirements ... when Fuji Dictation software is utilized. + Maintains a clear understanding of FDA requirements and ACR recommendation as well as local state regulations for… more
- Fujifilm (Raleigh, NC)
- …Manager. + Comply with all applicable US Food and Drug Administration (US FDA ) medical device regulatory requirements, applicable ISO 13485 standard requirements ... skills, self-starter a must along with ability to maintain paperwork to FDA and company required standards. + Excellent analytical and communication skills with… more
- Herbalife (Winston Salem, NC)
- …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 those that must… more
- Herbalife (Winston Salem, NC)
- …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 those that must… more
- Herbalife (Winston Salem, NC)
- …Electrical/Electronics + HVAC training /experience/ education + Food and Drug Administration ( FDA ) or other regulatory experience + Food 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 by an employee to successfully perform the essential functions of this… more
- Herbalife (Winston Salem, NC)
- …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, religion, sex, sexual… more
- Otsuka America Pharmaceutical Inc. (Raleigh, NC)
- …drug products and drug-device combination products. Ensure compliance with global regulations ( FDA , EMA, ICH, WHO) and anticipate regulatory changes impacting ... **Job Summary** The Chemistry, Manufacturing and Controls (CMC) Global Regulatory Affairs (GRA) professional is responsible for developing and executing global … more
- Otsuka America Pharmaceutical Inc. (Raleigh, NC)
- …approaches. + Ensure training content is accurate, current, and aligned with global regulatory requirements ( FDA , EMA, ICH). **Compliance & Risk Management** + ... cross-functional teams. + Strong understanding of R&D functions and the regulatory landscape (GxP, ICH, FDA , EMA, etc.). + Proven ability to design and deliver… more