- Abbott (Austin, TX)
- …requirements. + Complies with US Food and Drug Administration ( FDA ) regulations, other regulatory requirements, Company policies, operating procedures, processes, ... and task assignments. Maintains positive and cooperative communications and collaboration with all levels of employees, customers, contractors, and vendors. + Performs other related duties and responsibilities, on occasion, as assigned + Works with standard… more
- Actalent (Carlsbad, CA)
- …supervisors, colleagues, and stakeholders. + Comply with ISO Quality Management System, FDA 21 CFR Part 820 Quality System Requirements, and medical device industry ... requirements. + Assist in the implementation of the quality management system. Essential Skills + Understanding of quality assurance, GMP, GDP, and quality control principles. + Strong understanding of GMPs and GDP for production and generation of batch… more
- Avispa Technology (Tucson, AZ)
- …* Regulatory Familiarity: Experience in a regulated environment, familiar with FDA , ISO, and other relevant diagnostic product standards. * Strategic Mindset: ... Interest in innovative technologies and understanding of the IVD competitive landscape. * Specialized Skills: Deep knowledge in software reliability, manufacturability, and usability is preferred. (H) more
- Bristol Myers Squibb (Devens, MA)
- …experience in a regulated industry with 1+ year experience. Experience in FDA /EMA regulations in biopharmaceuticals or cell therapy manufacturing is preferred. + ... Demonstrated experience with electronic validation documentation systems. If you come across a role that intrigues you but doesn't perfectly line up with your resume, we encourage you to apply anyway. You could be one step away from work that will transform… more
- Edwards Lifesciences (Irvine, CA)
- …Experience with MedTech/healthcare workflows, EHR integration, clinical environments, or FDA /IEC usability standards strongly preferred + Basic understanding of ... front-end development (HTML/CSS) for effective collaboration + Strong and inspirational presentation skills, adaptable to various audiences ranging from design reviews to executive-level forums + Experience working with remote software engineering teams (ie… more
- IQVIA (Manassas, VA)
- …documents (such as but not limited to: Delegation of Authority Logs, Form FDA 1572s, Financial Disclosure Forms, etc.) for clinical studies being conducted at NEXT ... Oncology + Maintain current CVs and Medical Licenses for investigators + Maintain current training documents (GCP, HRS, etc.) in eDOCS for all NEXT Oncology staff + Receive incoming correspondence/files and review/forward to appropriate staff + Attend Phase I… more
- J&J Family of Companies (Wilson, NC)
- …standards. + Understanding and experience in application of global regulatory ( FDA , EMA, etc.) guidelines in a biological or pharmaceutical manufacturing ... environment. + Experience with regulatory inspections and response to observations. (QA Specialist, Compliance) + Proficiency in risk management methodologies such as FMEA. **Key Competencies - Other requirements** + An unquestionable level of integrity and… more
- J&J Family of Companies (Wilson, NC)
- …. Deep understanding and experience in application of global regulatory ( FDA , EMA, ICH, etc.) guidelines in a biological or pharmaceutical manufacturing ... environment. . Experience interacting with health authorities and taking a leading role in regulatory inspections and audits. **Preferred:** . Experience in supporting functional area (eg, Manufacturing, Technical Operations, Engineering & Maintenance, R&D,… more
- Lilly (Indianapolis, IN)
- …formulation and drug product considerations. + Strong regulatory interaction experience ( FDA , EMA, other health authorities). Lilly is dedicated to helping ... individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form (… more
- Astrix Technology (Piscataway, NJ)
- …process equipment operations, and related mechanical systems. + Knowledge of GMP, FDA , and other regulatory standards relevant to biotech facilities. + Strong ... analytical and problem-solving skills. + Excellent communication and teamwork abilities. + Ability to work flexible hours, including nights and weekends, as needed. _This job description is a complete list of all desired skills, but not all are required. We… more