- BioFire Diagnostics, LLC. (Durham, NC)
- …guidelines of bioMerieux's Quality System. Adhere to Regulatory requirements, including FDA , ISO, Legal, Ethical, and bioMerieux-specific procedures. + Source a ... variety of materials, equipment, and services in accordance with prescribed purchasing regulations and procedures + Master markets related to assigned categories/commodities, with a focus on soft-services. Seek of opportunities that serves Corporate… more
- BD (Becton, Dickinson and Company) (Mebane, NC)
- …signals up to 480 VAC Other Skills and Capabilities Preferred: + FDA compliant manufacturing experience + Experience with Lean Methodologies/TPM + Previous work ... experience with: + Basic Machining Equipment (Lathes, Mills, etc.) + Servo drive systems - preferably Allen-Bradley + Vision systems + Basic Pumping and Piping Systems + Electrical troubleshooting of circuits from low level signals up to 480 VAC At BD, we… more
- BioLife Plasma Services (Raleigh, NC)
- …QUALIFICATIONS:** + Experience working with SOPs, GDP, GMP, CLIA, and the FDA + Experience working in a highly regulated environment **We Offer Comprehensive ... Benefits from Day One** + Major medical, dental, and vision insurance and prescription coverage for eligible employees + A minimum of 15 vacation days and 10 company paid holidays + Tuition reimbursement + Retirement savings with a generous employer… more
- ThermoFisher Scientific (Greenville, NC)
- …build/refurbishment of sterile lines) would be beneficial. + Familiarity with US FDA , EU Annex-1 and other regulations and guidance. + Strong investigative skills, ... preferably familiar with Root Cause Analysis methods. + Leadership experience, and supervisory experience is helpful. + Shown expertise with audits and client-facing roles. + Outstanding technical writing skills + Influencing + cGMP Compliance + Strong sense… more
- ThermoFisher Scientific (Greenville, NC)
- …+ Bachelor's degree preferred + Regulatory Authority Inspections Experience ( FDA , MHRA, HEALTH CANAD, EMEA, etc.) + Experience leading cross-functional ... teams through the inspection readiness process and the inspections themselves. + **Minimum of 6+ years clinical research experience in pharmaceutical or biotechnology field** + **Solid knowledge of and experience in GCP compliance, regulatory inspection… more
- Amgen (Holly Springs, NC)
- …start-up or tech transfer projects + Expertise in global regulatory requirements ( FDA , EMA, etc.) + Strong background in laboratory compliance, LIMS, LMES, CIMS, ... Veeva and Trackwise systems + Lean Six Sigma or continuous improvement certification + Exceptional communication, leadership, and problem-solving skills + 2+ years of management experience at a senior level + Strong Leadership, Collaboration and Communication… more
- Otsuka America Pharmaceutical Inc. (Raleigh, NC)
- …operations. + Experience with cGMP manufacturing environments and regulatory requirements ( FDA , EMA, ICH). + Familiarity with process validation principles and CPV. ... + Strong analytical, problem-solving, and data interpretation skills (statistical analysis knowledge is a plus). + Excellent communication, collaboration, and influencing skills. + Ability to work effectively in a fast-paced, virtual environment. **Travel… more
- Cordis (Raleigh, NC)
- …all scientific/marketing materials adhere to relevant regulations and standards (eg, FDA , CA, PMDA,Sunshine Act) + Responsible for identifying clinical insights and ... knowledge gaps and be able to articulate the impact and magnitude of the findings. + Develops and maintains strong scientific knowledge of the current competitive landscape and competitive messaging. + Be a strategic partner to the overarching data… more
- Deloitte (Charlotte, NC)
- …familiarity with ICH guidelines (ie: ICH Q6A, Q7, Q8, Q9, Q10), FDA /EMA/PMDA regulations, and the structure/content of CMC sections in regulatory submissions (IND, ... NDA, BLA, MAA) + 1+ years experience leading, managing and delivering complex engagements with resources in multiple locations + Bachelor's Degree + Ability to travel up to 50% on average, based on the work you do and the clients and industries/sectors you… more
- Glenmark Pharmaceuticals Inc., USA (Monroe, NC)
- …Strong understanding of current GMPs and related regulatory health authority guidance ( FDA regulations, ICH guidelines, etc.) as they relate to the pharmaceutical ... industry. + Must be proactive, results-oriented with a strong attention to detail and strong time management skills. + Ability to manage multiple projects simultaneously, meet deadlines, and handle an ever-changing, fast-paced critical work environment. +… more