- Adecco US, Inc. (Buffalo, NY)
- …Plastics experience a huge plus. Medical or regulated environment with ISO and/or FDA certification strongly preferred (ISO 13485/ISO 14971 and 21 CFR Part 820 huge ... and the general public. **Skills/Technical Skills** + Communication Skills + Computer skills required, including Microsoft Office Applications, Lotus Notes, Graphic… more
- Unither Pharmaceuticals (Rochester, NY)
- …environment, or equipment and packaging technology *Experience in a regulated environment ( FDA ) a plus E. SPECIFIC SKILLS: This position requires the ability to ... technical troubleshooting, problem solving. *Detailed knowledge of equipment operation and validation requirements. *Ability to work in a matrix organization with… more
- Unither Pharmaceuticals (Rochester, NY)
- …environment, or equipment and packaging technology Experience in a regulated environment ( FDA ) a plus SPECIFIC SKILLS: This position requires the ability to think ... troubleshooting, problem solving. Detailed knowledge of equipment operation and validation requirements. Ability to work in a matrix organization...and laboratories. Must be able to work on a computer for extended periods of time. Must wear safety… more
- Jabil (Elmira, NY)
- …and strong organizational skills required. + Strong written, verbal communication, and computer skills required. + Experience with FDA regulations or ISO ... costs. + Support new equipment acquisition, including machine selection, installation, validation , and coordination of employee training and documentation. + Assist… more
- Sumitomo Pharma (Albany, NY)
- …programmers on SDTM/ADaM datasets and TLF specifications. + Perform programming validation for key derived datasets and oversee Quality Control (QC) efforts ... Bayesian Statistics + Good understanding and working knowledge of GCPs, ICH guidelines, FDA and other applicable country regulations is a plus + Advanced proficiency… more
- Sumitomo Pharma (Albany, NY)
- …+ Assist in signal detection activities including data assembly, signal validation , and signal evaluation. + Perform literature monitoring (with vendor support) ... oncology, and/or neurology is strongly preferred. + Comprehensive understanding of FDA and EU legislation and GCP/GVP/ICH safety guidelines for investigational and… more
- Ultralife Corporation (Newark, NY)
- …regulatory changes, and emerging trends. Education: Bachelor's degree in Engineering, Computer Science, or related field with demonstrated career in equivalent or ... roles. + Expertise in requirements management, risk management, verification, and validation . + Extensive experience with industry regulations (eg, ISO, CE, UL,… more
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