- Lilly (Concord, NC)
- …for training and benchmarking with other Lilly sites. + cGMP standards and FDA (or other industry) guidelines for production + HSE incident investigation, including ... multiple root cause analysis methods. + Facilitating employee safety teams, with the goal of turning over leadership to operations employees. + Managing a contractor safety program across a large footprint. + Implementation of electronic permit to work systems… more
- Abbott (Westfield, IN)
- …levels of management + Complies with US Food and Drug Administration ( FDA ) regulations, other regulatory requirements, Company policies and Business Units operating ... procedures **Required Qualifications** + Bachelor's degree in engineering or related field + Eight (8) years of medical device experience in R&D, Manufacturing and/or Quality Engineering + Excellent verbal and written communication skills, with the ability to… more
- University of Colorado (Aurora, CO)
- …+ Adhere to institutional, regulatory, and ethical guidelines, including HIPAA, CAP/CLIA, FDA , and NIH best practices. + Assist in developing and revising standard ... operating procedures (SOPs). **Collaboration & Administrative Support (10%)** + Serve as a liaison between clinical care teams, pathology personnel, and researchers. + Coordinate fulfillment of specimen requests and prepare shipments for approved… more
- AbbVie (Worcester, MA)
- …defend, persuade Corporate/Plant practices with outside organizations. Routinely meet with regulators ( FDA & EU) and customers to ensure no interruption in business ... due to compliance issues. + Directs area of responsibility to meet production objectives within planned budgets. Provides input to Supervisor for resources needed to construct budget, updates, and changes in financial plan. Supervises area supplies and… more
- Fujifilm (Holly Springs, NC)
- …* Ensures compendial method oversight and scientific guidelines (eg ICH, EMA, FDA , etc.) * Supports regulatory requests and inspections * Supports the QC ... AD team to investigate any project challenges with necessary risk assessment tools and techniques * Supports best practices for TT and PPQ strategies globally, as required * Performs other duties, as assigned **Minimum Requirements:** * BS in Chemistry,… more
- Actalent (Hercules, CA)
- …with relevant experience in microbiology. + 2+ years of GMP/GLP laboratory/ FDA experience. Additional Skills & Qualifications + BS/BA in Biology, Pharmaceutical ... Sciences, Biotechnology, or equivalent, with a preference for a Microbiology degree. + 2+ years of relevant microbiology experience or an Associate degree with 5+ years of experience in a related field, or a High school diploma with 7+ years of experience. +… more
- Fujifilm (Holly Springs, NC)
- …project-driven organization + Experience in a CGMP facility or working with FDA regulations Preferred Qualifications: + Prior experience in a similar role in ... large projects from conceptual design phase to operations + 4+ years of experience leading and developing leaders + Experience leading manufacturing or technical departments Physical Requirements: + May work in Mechanical/Production spaces that may require… more
- Kelly Services (Eagan, MN)
- …expertise with a strong technical background + In-depth understanding of FDA regulations and cGMP standards + Excellent communication skills-both written and ... verbal + Strong problem-solving, critical thinking, and innovation capabilities + Proven ability to lead projects independently and collaborate effectively + High attention to detail and organizational skills + Proficiency in Microsoft Office Suite Nice to… more
- Actalent (Springfield, MA)
- …the implementation of the Food Safety Plan and ensuring compliance with all applicable FDA regulations (21 CFR 111 and 117). Additionally, you will manage the site ... Quality Management System (QMS) and take responsibility for quality-related activities in warehouse and production operations, as well as working with co-manufacturers and managing supply chain preventive control, including approval and Foreign Supplier… more
- ZOLL Medical Corporation (Minneapolis, MN)
- …sleep disorders. Our core product is the WatchPAT(R)️ family, a revolutionary FDA -cleared portable home sleep apnea test device, that is based on proprietary ... signal and analysis. 80% of patients who have sleep apnea are undiagnosed. We are committed to reach those undiagnosed patients and provide testing to promote wellness and enhance overall quality of life. WatchPAT(R)️ is commercially available within major… more