- Endo International (Rochester, MI)
- …in QMS areas: deviation management and/or change control + Conducts investigations for cause, determines corrective action, and impact; writes reports and ... of a safe manufacturing environment. Establishes methods in compliance with regulatory , plant, and corporate policies. Participates in safety meetings, investigates… more
- Cambrex High Point (Charles City, IA)
- …principles of cross-functional departments, including organic chemistry and engineering. GMP/ Regulatory Knowledge: D emonstrated understanding of GMP as it relates ... work; with less manager input, can help advise clients on key regulatory strategies. Instrumentation: Demonstrated ability to use, train, investigate root cause… more
- Lilly (Indianapolis, IN)
- …to maintain our HVAC/Utilities programs up to date with industry standards, external/ internal regulatory documents, and regulatory agencies expectations. ... for their system(s). + Responsible for all CAPA and observation / deviation investigations and originations (eg, root cause analysis). + Deviation Owner for assigned… more
- Grifols Shared Services North America, Inc (Lithonia, GA)
- …implements processes, regulations and SOPs for quality control and overall regulatory compliance, making independent decisions and modifications as required. * ... Oversight of all aspects of internal and external audits including execution (if applicable). This includes documentation, review of and preparation of the response.… more
- Beth Israel Lahey Health (Plymouth, MA)
- …loss and analyzes the impact on the organization. + Oversee and manage the internal Adverse Event reporting function as a critical element of the system's safety ... 72 hours of the event. Review and analyze event reports, conduct investigations and follow-up with appropriate management staff. + Support, provide guidance, and… more
- BD (Becton, Dickinson and Company) (Humacao, PR)
- …transit simulation, and bioburden) in accordance with industry standards and internal protocols. + Lead packaging-related investigations , root cause analysis, ... This role is responsible for ensuring packaging systems meet performance, regulatory , and operational requirements. The engineer will work closely with… more
- BD (Becton, Dickinson and Company) (Irvine, CA)
- …complaint handling unit, and evaluation of events for reportability to applicable regulatory bodies. **Job Description** We are **the makers of possible** BD is ... from Product Safety, Engineering and other departments/business units for complaint investigations + Evaluate complaints for Medical Device Reporting (MDR) + Prepare… more
- GE Vernova (Rochester, NY)
- …apply best-in-class reliability engineering methodologies to ensure system resilience, regulatory compliance, and long-term field performance. Your work will ... participation, standards leadership, and technology strategy. + Stay current on regulatory compliance requirements (eg, NERC, IEEE, IEC standards) impacting utility… more
- Integra LifeSciences (Braintree, MA)
- …process data. + Assist in preparing for, and participating in FDA audits, internal audits, and other regulatory agencies audits. + Demonstrate excellent ... Control Microbiology team. This role also involves supporting non-conformance investigations , identifying root causes, and contributing to the continuous improvement… more
- Bio-Techne (Minneapolis, MN)
- …agencies on regulations, permitting, and compliance. Assists in the preparation of regulatory and internal company reports as required. Manage and troubleshoot ... Specialist with 3-5 years of experience to lead safety initiatives, ensure regulatory compliance, conduct risk assessments, and foster a culture of workplace safety… more