- Glenmark Pharmaceuticals Inc., USA (Allentown, PA)
- …to ensure compliance with pharmaceutical traceability and labeling standards + Maintain FDA and DEA regulatory compliance by ensuring cleanroom integrity and ... system-directed tasks using RF scanners integrated with Manhattan WMS. + Perform quality checks to ensure shipment integrity, proper labeling, and compliance. +… more
- West Pharmaceutical Services (Williamsport, PA)
- …experience working in the **medical device industry** with a strong understanding of regulatory requirements ( FDA , ISO 13485, GMP) would be an advantage. + ... with ISO 13485, and GMP requirements, while driving continuous improvement in quality , efficiency, and cost. **Essential Duties and Responsibilities** + Lead and… more
- PCI Pharma Services (Philadelphia, PA)
- …teams, overseeing technical projects, ensuring adherence to safety and quality standards, and continuously improving processes to enhance productivity and ... of manufacturing processes to improve efficiency, reduce costs, and maintain high- quality standards. + Drive continuous improvement initiatives (eg, Lean, Six Sigma)… more
- Fujifilm (Harrisburg, PA)
- …+ Comply with all applicable US Food and Drug Administration (US FDA ) medical device regulatory requirements, applicable ISO 13485 standard requirements ... and or post go-live support cases in compliance with the company's quality procedures. **Company Overview** At FUJIFILM Healthcare Americas Corporation, we're on a… more
- Globus Medical, Inc. (Audubon, PA)
- …ensure timely completion of tasks while remaining in full compliance with Globus quality system and other applicable regulatory bodies + Partnering with ... we move with a sense of urgency to deliver innovations that improve the quality of life of patients with musculoskeletal disorders. Our team is inspired by the… more
- Sanofi Group (Swiftwater, PA)
- …in accordance with current good manufacturing practices (cGMP) for all relevant regulatory agencies (eg FDA ). Positions within production facilities may change ... 120 million doses of injectables that help prevent diseases and enhance patients' quality of life. Our teams follow current Good Manufacturing Practices (cGMP) and… more
- Catalent Pharma Solutions (Philadelphia, PA)
- …understanding of financial and business concepts. + Experience working to regulatory standards: FDA , Good Engineering Practice (GEP), Good Manufacturing ... of commercial and late-stage clinical products efficiently, timely, and with high quality . Scope of the role covers the entire product lifecycle including M&A,… more
- Charles River Laboratories (Wayne, PA)
- …Testing Solutions** With more than 50 years of experience and proven regulatory expertise, the Charles River Biologics group can address challenging projects for ... we are passionate about our role in improving the quality of people's lives. Our mission, our excellent science...drugs approved by the US Food and Drug Administration ( FDA ) in the past five years. We're committed to… more
- ThermoFisher Scientific (King Of Prussia, PA)
- …digital and decentralized clinical trial services. Your determination to deliver quality and accuracy will improve health outcomes that people and communities ... and particle formation in protein therapeutics. + Provide high quality data and aid in drafting of sections for...aid in drafting of sections for characterization reports and regulatory submissions. Keys to Success **Education and Experience** +… more
- Globus Medical, Inc. (Audubon, PA)
- …ensure timely completion of tasks while remaining in full compliance with Globus quality system and other applicable regulatory bodies + Designing and developing ... sense of urgency to deliver innovations that improve the quality of life of patients with musculoskeletal disorders. Our...product development + Creating and maintaining project plans and FDA complaint Design history Files (DHF) for each project… more