- Mentor Technical Group (NC)
- …provides a comprehensive portfolio of technical support and solutions for the FDA -regulated industry. As a world leader in life science engineering and technical ... solutions, MTG has the knowledge and experience to ensure compliance with pharmaceutical, biotechnology, and medical device safety and efficacy guidelines. With offices in Caguas, Puerto Rico, and Boston, United States, we serve life sciences clients in six… more
- Grifols Shared Services North America, Inc (Clayton, NC)
- …year pharmaceutical, chemical, and/or production manufacturing experience in a regulated industry ( FDA , USDA, NRC) obtained within the last 5 years (completion of ... the "Bioworks Certification Program" through a community college a plus) or + Graduation from an accredited college/university with an Associate's or Bachelor's degree in: Biology, Chemistry, Biochemistry, Engineering, Pharmaceutical Technology, Business,… more
- Edwards Lifesciences (Raleigh, NC)
- …R, S-Plus + Thorough understanding of regulatory guidelines (GCP, ICH, FDA , ISO) for pharma/medical devices + Excellent problem-solving, analytical, and critical ... thinking skills + Proven leadership and ability to influence change + Skilled in training/coaching and facilitating organizational change + Detail-oriented; able to manage competing priorities in fast-paced environments + Professional interaction across all… more
- Edwards Lifesciences (Raleigh, NC)
- …and performance oversight. + Expertise in medical writing processes, regulatory requirements ( FDA , EU MDR), GCP, and ICH guidelines. + Advanced knowledge of ... biomedical statistics, clinical literature review, and therapeutic/product operations. + Skilled in Microsoft Office Suite and publication/database tools (EndNote, Medline, PubMed). + Exceptional problem-solving, analytical, and communication skills; ability… more
- Sumitomo Pharma (Raleigh, NC)
- …combination products) is required. Must be familiar with EMA and FDA validation requirements, including Lifecycle Model. Lean Six Sigma training/certification is ... preferred The base salary range for this role is $173,200 to $216,500. Base salary is part of our total rewards package which also includes the opportunity for merit-based salary increases, short incentive plan participation, eligibility for our 401(k) plan,… more
- Teleflex (Morrisville, NC)
- …discipline preferred * 5-10 years of experience working within an FDA regulated industry, Medical Device preferred * Advanced problem solving and ... root cause analysis * Advanced knowledge of 21 CFR 820, ISO 13485, and ISO 9001 (with emphasis on purchasing controls) * Knowledge of statistical techniques * Minimum 5 years of auditing experience (3rd party certification preferred) * Engineering degree or… more
- Norstella (Raleigh, NC)
- …and biotech companies around the world, along with regulators like the FDA , and payers. By providing critical proprietary data supporting AI-driven workflows, ... Norstella helps clients make decisions faster and with greater confidence. Norstella's investments in AI are transforming how data is consumed and decisions are made, disrupting inefficient legacy workflows and helping the industry become more efficient,… more
- ITG Brands (NC)
- …housekeeping, procedures, and responsibility associated with the area of GMP and FDA guidelines. + Compile and analyze production records and ensure that production ... plans are completed by a certain time, organize workflow by assigning responsibilities and preparing schedules and coordinate appropriate activities and stakeholders to identify and eliminate obstacles as well as identify, suggest, and implement improvements.… more
- Parexel (Raleigh, NC)
- …knowledge of clinical trial methodologies, ICH/GCP, Food and Drug Administration ( FDA ) and local country regulations + Monitoring Experience: Minimum 3 years ... relevant experience in clinical research site monitoring (preferably 2 years in Oncology) + Preferred therapeutic experience in Oncology, Vaccines, Internal Medicine or Infectious Diseases + Must be fluent in English and in the native language(s) of the… more
- Mentor Technical Group (Monroe, NC)
- …provides a comprehensive portfolio of technical support and solutions for the FDA -regulated industry. As a world leader in life science engineering and technical ... solutions, MTG has the knowledge and experience to ensure compliance with pharmaceutical, biotechnology, and medical device safety and efficacy guidelines. With offices in Caguas, PR, Boston, MA & San Francisco, CA and we serve life sciences clients in six… more