- Sutter Health (Castro Valley, CA)
- …Security (DHS), Drug Enforcement Administration (DEA), Food and Drug Administration ( FDA ), and United States Pharmacopeia (USP). + Possess written and verbal ... communications skills to explain sensitive information clearly and professionally to diverse audiences, including non-medical people. + General knowledge of computer applications, such as Microsoft Office Suite (Word, Excel and Outlook), related pharmaceutical… more
- Actalent (South San Francisco, CA)
- …in Veeva CDMS system. + Strong working knowledge of CDISC standards, FDA and ICH/GCP regulations and guidelines. + Proficiency in configuration and design, ... testing and validation, data collection and data review process, and data standardization. Additional Skills & Qualifications + Strong experience with late-phase oncology trials is preferred. + Experience with CDASH, CRF, and WhoDrug medical coding. + Ability… more
- Northwell Health (Great Neck, NY)
- …established policies and procedures. 8.Complies with Food and Drug Administration ( FDA ) mandates and self-imposed manufacturer restrictions on particular drugs, as ... applicable including Risk Evaluation and Mitigation Strategy (REMS) programs and manufacturer limited distribution drug requirements. 9. Maintains current knowledge of, and complies with, standards of specialty accrediting bodies (eg, URAC, ACHC), and annual… more
- Bristol Myers Squibb (Devens, MA)
- …cGMP regulations and guidance. + Knowledge and proven experience in FDA , EMA, or other regulatory authority. + Demonstrated leadership, interpersonal, communication, ... and motivation skills. + Directs quality initiatives that accomplish continuous improvement and enhance site manufacturing efficiencies, while providing a safe and compliant process. + Must be action-oriented and customer-focused and skilled in… more
- Reckitt (Wilson, NC)
- …cGMP guidelines, the global regulatory authorities for pharmaceutical development including FDA , MHRA and EMA, the relevant industry guidelines, and the Occupational ... Safety and Health Administration regulations. Utilize experience and knowledge to develop innovative approaches to deliver improvements in a collaborative manner across the business and influence actions through the support of others. **_This role is not… more
- L'Oreal USA (North Little Rock, AR)
- …+ Strong knowledge of quality management systems, regulatory requirements (ISO 9001, ISO 22716, FDA 21 CFR 210 and 211). ISO 17025 is a plus. + Excellent analytical, ... problem-solving, and decision-making skills. + Effective communication skills, both written and verbal. + Detail-oriented with a strong focus on accuracy and precision. + Good computer skills with proficiency of Microsoft tools (Excel, Word, PowerPoint, etc) +… more
- J&J Family of Companies (Danvers, MA)
- …of Medical Device Design Controls and Product Life cycle + Knowledge of FDA and EU MDR regulations + Ability to communicate ideas and information clearly, ... effectively, and frequently (oral and written) with stakeholders, project team, local and international. + Ability to exercise independent judgment in methods, techniques and evaluation criteria for obtaining results. + Ability to act independently to resolve… more
- Rise Baking Company (York, PA)
- …building in a manner that meets and complies with all food safety policies, FDA and OSHA regulations. Essential Functions + Perform basic wash area duties including ... running a pan washer, cleaning utensils by hand when needed, etc. + Perform basic machine disassembly/setup for cleaning (eg, covers, piping, cover electrical with plastic) + Complete cleaning tasks per SSOPs + Recognize and address equipment needing deep… more
- Philips (San Diego, CA)
- …combined experience in Clinical Research and/or Medical/Clinical Affairs within an FDA regulated medical device industry, and direct patient care activities, with ... a focus on cardiac monitoring products like wearable/Holter monitors, event recorders, or implantable loop recorders. + You demonstrate knowledge of ECG tracing interpretation and arrythmia mechanisms. + You're able to effectively manage, communicate,… more
- Insight Global (Lower Gwynedd, PA)
- …the technical expert. Understand and have a strong knowledge of cGMPs, FDA and other advance therapy regulations, sterile/aseptic processing. Designing and leading ... cycle development technical studies, as applicable, for various technical equipment including isolators, controlled rate freezers, etc. Create and maintain documentation such as batch production records, operational procedures, criticality analysis, user… more
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