- BioFire Diagnostics, LLC. (Durham, NC)
- …expectations, and quality standards. Primary Duties + Perform all work in compliance with company policy and within the 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… more
- BioLife Plasma Services (Raleigh, NC)
- …develop the skills to meet production and cost goals while ensuring compliance with regulations and BioLife SOPs. + **Travel Opportunities:** Through our ... QUALIFICATIONS:** + Experience working with SOPs, GDP, GMP, CLIA, and the FDA + Experience working in a highly regulated environment **We Offer Comprehensive… more
- Otsuka America Pharmaceutical Inc. (Raleigh, NC)
- …This role is responsible for ensuring the robustness, scalability, and compliance of downstream operations through effective technology transfer, validation support, ... operations. + Experience with cGMP manufacturing environments and regulatory requirements ( FDA , EMA, ICH). + Familiarity with process validation principles and CPV.… more
- Cordis (Raleigh, NC)
- …about off-label products or indications + Collaborate with regulatory and compliance teams to ensure 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… more
- Teleflex (Morrisville, NC)
- …newly implemented or existing systems and processes according to quality, compliance , and regulatory requirements * Identify and address technical or operational ... working understanding of technology across many disciplines + Working knowledge of SOX and FDA 21 CFR Part 820 requirements + Firm understanding of IT best practices… more
- Amazon (Durham, NC)
- …a licensed Pharmacist who is responsible for the operation oversight and compliance of a small format pharmacy site, including; safety, quality, customer experience, ... with requirements and demands of accrediting/licensing bodies (BOP, VIPPS, URAC, DEA, FDA , USP) * Responsible for the site's growth and partnering with capacity… more
- Lilly (Durham, NC)
- …a member of the RTP IT leadership team. + Promote a culture of compliance aligned with internal and external computer system quality standards. + Advocate for ... Validation in line with pharmaceutical computer system quality regulations (eg cGMP's, FDA 21 CFR Part 11) and other applicable regulations (eg privacy, OSHA,… more
- West Pharmaceutical Services (Kinston, NC)
- …issues as needed. + Ensure that all projects and activities are in compliance with local, regional and best practice requirements and meet other applicable authority ... operations; prefer SAP and MS Office applications. + Experience working with ISO9000, FDA and cGMP preferred + Understanding and experience in use of Lean… more
- Grifols Shared Services North America, Inc (Clayton, NC)
- …drawings are as-built, document commissioning, prepare turnover package. + Ensure compliance with company, environmental, building code, and regulatory policies and ... utility systems. + These new utility systems are to support the FDA licensed blood fractionation, purification, and filling operations. Pharmaceutical experience is… more
- 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… more