- BioFire Diagnostics, LLC. (Durham, NC)
- …+ In-depth knowledge of global HSE regulations and standards (OSHA, EPA, ISO 14001/45001, FDA QSR, EU MDR, etc.). + Experience in building and improving a Health ... Safety and Environmental management system + Demonstrated ability to lead cross-functional teams and influence at all levels of the organization. + Flexible, innovative, continuous improvement and result-oriented + Strong analytical, communication, and project… more
- Reckitt (Wilson, NC)
- …fulfill relevant regulatory requirements including compliance with company requirements, FDA regulations, and state/federal EHS requirements. + Prepare project ... budgets and cash flow projections. + Create project implementation timelines ie milestone and detailed project schedules. + Prepare capital appropriation requests and route to obtain management approval. + Potentially manage up to 3 direct reports to coach,… more
- RELX INC (Raleigh, NC)
- …strategy. This role ensures compliance with industry regulations (such as GxP and FDA 21 CFR Part 11), oversees daily operations, drives software development best ... practices, and manages global teams. You will be responsible for planning and executing product delivery while fostering innovation in cloud architecture, security, and software development. Conditions of Employment: + You must be a US citizen to apply for… more
- Fujifilm (Holly Springs, NC)
- …in Validation, cGMP manufacturing operations and/or Quality oversight, in an FDA regulated facility. * High level of familiarity/understanding of validation of ... production equipment, hygienic utilities, quality systems, automation, manufacturing & IT Systems, and methodologies * Understanding of GAMP5, Data Integrity, and application of 21 CFR Part 820 and Part 11 **Preferred Requirements:** * Working knowledge of… more
- Grifols Shared Services North America, Inc (Clayton, NC)
- …of pharmaceutical , chemical and/or production manufacturing experience in a regulated industry ( FDA , USDA, NRC) obtained within the last 5 years OR Graduation from ... an accredited college/university with an Associate's or Bachelor's degree in: Biology, Chemistry, Biochemistry, Engineering, Pharmaceutical Technology, Business, Teaching or a related curriculum OR Completion of the Bioworks Certification Program Tech II: In… more
- Kelly Services (Clayton, NC)
- …of relevant experience **Preferred Experience:** + Experience interfacing with the FDA , including license submissions, inspections, and audit follow-up + Background ... in aseptic/sterile manufacturing environmentsAs part of our promise to talent, Kelly supports those who work with us through a variety of benefits, perks, and work-related resources. Kelly offers eligible employees voluntary benefit plans including medical,… more
- West Pharmaceutical Services (Kinston, NC)
- …operations; prefer SAP and MS Office applications. + Experience working with ISO9000, FDA and cGMP preferred + Understanding and experience in use of Lean ... manufacturing principles preferred + Ability to write routine reports, correspondence, and process documents. + Excellent organizational and communication skills. + Works independently with minimal guidance. + Able to be aware of all relevant SOPs as per… more
- Lilly (Concord, NC)
- …experience. + Understanding of basic requirements of regulatory agencies such as the FDA , EMEA, DEKRA, and OSHA, or other similar groups + Excellence in; electronic, ... written, and oral communication skills + Strong technical aptitude as demonstrated through previous work or educational accomplishments **Additional Skills/Preferences:** + Working within or directly supporting pharmaceutical, food, packaging, or applicable… more
- Fujifilm (Durham, NC)
- …actions. + Proficiency in validation documentation and regulatory standards (eg, FDA , EMA). + Familiarity with continuous improvement methodologies and tools. + ... Strong leadership and communication skills for managing project teams and stakeholder relationships. + Proficiency in project controls software and integration with corporate systems. + Ability to analyze complex data sets and provide actionable insights and… more
- Grifols Shared Services North America, Inc (Clayton, NC)
- …utility systems. + These new utility systems are to support the FDA licensed blood fractionation, purification, and filling operations. Pharmaceutical experience is ... not required but shall be considered a plus for the candidate. This job description is intended to present the general content and requirements for the performance of this job. The description is not to be construed as an exhaustive statement of duties,… more