- Chiesi (Cary, NC)
- …than 6,000 employees (Chiesi Group). To achieve its mission of improving people's quality of life by acting responsibly towards society and the environment, the ... newly created position will initially focus on pre-launch preparation in anticipation of FDA approval of our global market leading product, Trimbow(R). We want to… more
- ThermoFisher Scientific (Greenville, NC)
- …improvements and efficiencies. + Coordinate regulatory inspections performed by the FDA , MCA, and other agencies. + Defend policies, procedures, rationales, and ... methods during regulatory and client audits. + Establish and supervise quality programs and plans, such as validation, QAT, and supplier certification.… more
- Compass Group, North America (Charlotte, NC)
- …print * Farm to Fork * Special Dietary Needs (food allergies, intolerances) * Quality Assurance **Job Responsibilities (May include any or all)** : * Safety: Safe ... * Support educational nutrition campaigns * Executing operational standards * Managing FDA regulation standards * Market Research * Manage website and social… more
- Sumitomo Pharma (Raleigh, NC)
- …(SmPC), and Canadian Product Monograph (PM) + Ensures timely and quality review and assessment of ICSRs, including seriousness, expectedness, safety narratives, ... and risk management regulations and guidelines, including pre- and post-marketing US FDA and/or EU ICH safety requirements** + Expertise in medical review of… more
- Herbalife (Winston Salem, NC)
- …for all activities that either directly or indirectly affect product safety and quality . The individual will work onsite at our state of art Innovation and ... Automation/Electronics or Industrial Maintenance Technology/Mechatronics * Food and Drug Administration ( FDA ) or other regulatory experience * 5+ years of work… more
- Fujifilm (Raleigh, NC)
- …and procedures. + Effective communication within FUJIFILM IVD organization of sales, quality and compliance issues. + Utilization of the IVD reporting systems for ... + Comply with all applicable US Food and Drug Administration (US FDA ) medical device regulatory requirements, applicable ISO 13485 standard requirements and all… more
- United Therapeutics (Research Triangle Park, NC)
- …pulmonary arterial hypertension ( **PAH** ). Today, we have six FDA -approved therapies that treat PAH, pulmonary hypertension associated with interstitial lung ... time management skills with ability to multi-task without compromising quality + Excellent communication and documentation skills **Preferred Qualifications** +… more
- Kelly Services (Durham, NC)
- …* Join a leading company in the pharmaceutical industry committed to innovation and quality . * Enjoy a dynamic work environment focused on safety and teamwork. * ... and stand for up to a 12-hour shift. * Bio works preferably or FDA environmental experience (1-3 years required) Helping you discover what's next in your career… more
- Grifols Shared Services North America, Inc (Clayton, NC)
- …labeling against approved artwork using proofreading skills * Interacts with Quality Operations Incoming Inspection, QO Release, Biochemistry and Packaging to ... Strong knowledge of compliance standards with the Food Drug Administration ( FDA ), international governing entities and Good Manufacturing Practices (GMPs) +… more
- IQVIA (Durham, NC)
- …and regulatory submission requirements, reviews study submission data packages to ensure quality and integrity. + Works closely with study leads and Data Management ... + Expert knowledge of SDTM and ADaM data standards and FDA /PMDA/EMA submission requirements required + Therapeutic experience in Oncology, Virology, and/or… more