- WuXi AppTec (Middletown, DE)
- …construction management, schedule, safety management, process, commissioning & qualification per GMP/ FDA compliance. + Own the development and delivery of the ... and regulations while maintaining international standards + Good acknowledge of GMP/ FDA /ICH and implementation + Strong teamwork spirit + Strong communication and… more
- UPMC (Pittsburgh, PA)
- …of their specific projects. + Routinely monitors all trials for compliance with FDA , UPMC and IRB compliance; promptly and effectively reports any issues to ... and retrospective data. + Oversee and coordinate governmental audits such as the FDA and NCI. + Develop and maintain outcomes and disparities clinical research… more
- Mentor Technical Group (Juncos, PR)
- …provides a comprehensive portfolio of technical support and solutions for the FDA -regulated industry. As a world leader in life science engineering and technical ... equipment (both upstream and downstream). + Strong knowledge of GMP, FDA , cGMP, and international regulatory requirements. + Hands-on experience developing and… more
- Mentor Technical Group (Juncos, PR)
- …provides a comprehensive portfolio of technical support and solutions for the FDA -regulated industry. As a world leader in life science engineering and technical ... English; additional language skills are a plus. Preferred Skills: + Experience with FDA , EMA, or other regulatory inspections. + Familiarity with software tools used… more
- Balchem (Faribault, MN)
- …integrate quality systems across sites. Knowledge & Experience: + Operated in an FDA regulated environment, ideally food or dietary supplement + Assess and mitigate ... experience in food, supplement, or related industry, including management. + Familiarity with FDA , HACCP, SQF, and industry best practices. + Ability to lift 50… more
- MPE Inc. (Sturtevant, WI)
- …activities in metal fabrication + Ensure all manufacturing processes comply with FDA , ISO 13485, and other relevant medical device industry regulations. + Monitor ... + Strong knowledge of fabrication techniques and processes + Familiarity with FDA , ISO 13485, and other relevant regulatory standards. + Proven ability to… more
- Mentor Technical Group (Juncos, PR)
- …provides a comprehensive portfolio of technical support and solutions for the FDA -regulated industry. As a world leader in life science engineering and technical ... equipment in pharmaceutical or biopharmaceutical industry. + Strong knowledge of cGMP, FDA , EMA, and ICH guidelines. + Experience with bioreactors, fermenters, cell… more
- Takeda Pharmaceuticals (Boston, MA)
- …Oversees and leads all clinical science activities involved in interactions with FDA , other regulatory agencies and key opinion leaders relevant to assigned ... Multiple experience in preparing and interacting with multiple regulatory agencies including FDA , EMA, and others + Multiple NDA/MAA submission experience + Proven… more
- J&J Family of Companies (Danvers, MA)
- …Quality & Regulatory Compliance** + Maintain alignment with regulatory expectations (eg, FDA QSR/21 CFR Part 820, ISO 13485) and support regulatory submissions as ... operations within medical devices or complex product environments. + Deep understanding of FDA QSR/21 CFR Part 820 and ISO 13485. + Experience with design controls,… more
- AbbVie (Mettawa, IL)
- …accurate, competitive and compliant with internal policies. Code of Federal Regulations (CFR), FDA guidance documents, PhRMA Guiding Principles, and the FDA and ... cosmetic Act. + Development and guides implementation strategies for promotional activities + Broadly applies regulatory/technical knowledge of government regulations and skills across therapeutic areas. + Ensure departmental training and compliance with… more