- System One (East Windsor, NJ)
- …as needed for production support. + A familiarity with cGMPS, CFRs, OSHA and FDA regulations. System One, and its subsidiaries including Joule, ALTA IT Services, and ... Mountain Ltd., are leaders in delivering outsourced services and workforce solutions across North America. We help clients get work done more efficiently and economically, without compromising quality. System One not only serves as a valued partner for our… more
- Abbott (Menlo Park, CA)
- …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. **Required… more
- Eurofins US Network (New Berlin, WI)
- …* Working knowledge of Microbiological testing preferred* Understanding of regulatory standards ( FDA , EPA, USDA) and lab operations helpful + **Business Acumen:** * ... Experience managing budgets, KPIs, and operational metrics* Confident with business planning, client proposals, and capital decisions* Entrepreneurial mindset with strong follow-through **Additional Information** **Why Eurofins?** Eurofins is a global leader… 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
- Globus Medical, Inc. (Eagleville, PA)
- …Technician is responsible for assembling medical devices in compliance with applicable FDA , state, OSHA, and ISO regulations and standards. This effort includes, but ... is not limited to, to be a team player with the ability to function well in a challenging and fast paced environment. This individual works with the entire department to ensure products are made up to company standards. **Essential Functions** **:** +… more
- BD (Becton, Dickinson and Company) (Columbus, NE)
- …for raw materials in the plant. + Assist in Internal audits and ISO/ FDA audits. + Responsible for issuing/ tracking supplier quality issues, notifications, alerts. + ... Work closely with Purchasing on Supplier related activities. + Follow up to suspected defective material reported by Production. + Other duties as required to support the needs of the business. **Education:** + High School diploma/GED required **Experience:**… more
- Actalent (South San Francisco, CA)
- …industry and clinical trial processes. + Strong knowledge of CDISC standards, FDA and ICH/GCP regulations and guidelines. Additional Skills & Qualifications + CRO ... or CDM vendor management experience in oncology. + Early phase adaptive trial management experience preferred. + Experience with CDASH terminology. + Experience with R or SAS programming techniques is a plus. + Experience with Rave is a plus. + Experience with… more
- United Therapeutics (Research Triangle Park, NC)
- …pulmonary arterial hypertension ( **PAH** **)** . Today, we have six FDA -approved therapies that treat PAH, pulmonary hypertension associated with interstitial lung ... disease ( **PH-ILD** ) and neuroblastoma, a rare pediatric cancer. Our near-term pipeline seeks to develop additional therapies for PAH and pulmonary fibrosis ( **PF** ). The cure for end-stage life-threatening diseases like PAH, PH-ILD, PF, and many others is… more
- Actalent (Lenexa, KS)
- …work, or an equivalent combination of education and experience. + Familiarity with FDA regulations for medical devices. + Ability to manage tasks in an organized ... fashion and communicate effectively with various departments. + Intermediate computer skills, preferably with Microsoft Word, Excel, and PowerPoint. + Experience working in SAP is a plus. + Ability to follow written and verbal instructions and adapt to new… more
- Herbalife (Winston Salem, NC)
- …these lifts. Experience: + A minimum of 2 years of experience in FDA or GMP regulated industry Education: + High-school diploma (or equivalent) PREFERRED ... QUALIFICATIONS: + Experience with food, supplement or pharmaceutical manufacturing + Knowledge and understanding of GMP quality systems At Herbalife, we value doing what's right. We are proud to be an equal opportunity employer, making decisions without regard… more
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