- BioFire Diagnostics, LLC. (Durham, NC)
- …working a 2-2-3 rotation schedule. This position is in a fast-paced, FDA regulated environment in the Medical Devices/Diagnostics Industry. The QC Biochemistry ... executing validation protocols associated with Biochemistry laboratory equipment, associated software , and procedures including revalidation as scheduled or required… more
- Actalent (Winston Salem, NC)
- …+ Ensure continued GxP compliance of QC laboratory computer systems and software . + Perform additional duties and projects as assigned by management. Essential ... Understanding of full compliance for lab instrumentation, validation protocols, FDA compliance, audit, lab equipment, IQ, OQ, PQ. +...audit, lab equipment, IQ, OQ, PQ. + Audit and FDA experience. Additional Skills & Qualifications + Education in… more
- Biomat USA, Inc. (Research Triangle Park, NC)
- …Responsibilities:** + Ensures compliance with Food and Drug Administration ( FDA ) regulations and all policies, guidelines, and standard operating procedures ... and Abilities:** + Strong knowledge of Food and Drug Administration ( FDA ) regulatory requirements for good manufacturing practices. + Demonstrated spreadsheet and… more
- Medtronic (Charlotte, NC)
- …in the operating room, so healthcare/surgical setting experience + Familiarity with FDA product requirements and regulatory guidelines + Experience with robotics or ... understand schematics and engineering drawings + Familiar with the FDA 21 CFR, CGMP for Medical devices + Demonstrable...Microsoft Office products as well as ERP and CRM software packages (such as SAP, ServiceMax and SalesForce.com) +… more
- Fujifilm (Raleigh, NC)
- …Speech Recognition tools, as well as actual dictation functionality when Fuji Dictation software is utilized. + Maintains a clear understanding of FDA ... + Comply with all applicable US Food and Drug Administration (US FDA ) medical device regulatory requirements, applicable ISO 13485 standard requirements and all… more
- Otsuka America Pharmaceutical Inc. (Raleigh, NC)
- …understanding of the drug development process, laws, regulations, and guidelines including FDA , ICH, etc. - Able to successfully interpret and apply regulatory ... etc.) in pharmaceutical or healthcare related industry. Experience with FDA or other health authority interactions desirable. **Competencies** **Accountability for… more
- Glenmark Pharmaceuticals Inc., USA (Monroe, NC)
- …Critical Investigations to align with corporate guidelines. + Comply with applicable FDA and international regulatory laws/standards and the Code of Conduct. + ... the Stability and Quality Control departments. + Represent Glenmark as appropriate in FDA , notified body, internal and other regulatory audits. + Work in close… more
- Lilly (Durham, NC)
- …effectively in a team-based environment. + Strong computer skills in a variety of software packages (Microsoft Office, etc). + Ability to work in a safe manner to ... Ability to troubleshoot equipment or process problems. + Knowledge of automation systems/ software to facilitate data collection + Working knowledge of vision systems… more
- Alaka'ina Foundation Family of Companies (Camp Lejeune, NC)
- …policies and procedures concerning the conduct of clinical trials, including FDA Good Clinical Practice (GCP), International Council on Harmonization (ICH) ... style and vocabulary. + Skill in using desktop and networked computer software , to include intermediate or advanced level competencies with Microsoft Windows and… more
- Cambrex High Point (High Point, NC)
- …levels of the organization and have basic knowledge of computers and industry-related software . + Ability to work effectively under pressure to meet deadlines. + ... Ensures compliance with company policies and SOPs as well as FDA and other applicable guidelines. Qualifications/Skills Fundamental understanding (experience is not… more