- Cambrex High Point (Longmont, CO)
- …dose drug product. * Experienced with review and approval of equipment and instrument validation as well as associated computer software validation . * ... that all activities are in compliance with company SOPs, cGMP/cGLP standards and FDA /EU regulations. The Manager of Quality Assurance leads and mentors the quality… more
- Antech Diagnostics (Loveland, CO)
- …on emerging security threats, vulnerabilities and mitigation techniques. **Product Security Validation ** + Organize and support the product security review process + ... delivery and required level of quality in all aspects of the validation process. + Provide Standardized product security documentation. + Collaborate with other… more
- Medtronic (Lafayette, CO)
- …including numerical verification + Defines and performs verification and validation activities, ensuring products meet user needs, system requirements, and ... methodologies, including requirements development, analysis, allocation, review, tracing, and verification/ validation + Ability to effectively communicate and work collaboratively… more
- Sumitomo Pharma (Denver, CO)
- …signal management throughout product lifecycle including signal detection, signal validation , signal escalation, development of risk mitigation strategies and ... aggregate review of post-marketing safety data in support of safety signal validation , trend detection, risk benefit management, and development of risk mitigation… more
- Sumitomo Pharma (Denver, CO)
- …policies, processes, and systems to enable accurate and timely data capture, validation , and reporting + Oversee and directly manage the collection, integration, and ... + Strong knowledge of regulations and guidance related to FDA , OIG, CMS, FTC, and PhRMA + Strong knowledge...communication skills required. Requires ability to use a personal computer for extended periods of time. **Sumitomo Pharma America… more
- Cognizant (Denver, CO)
- …delivery with benefits delivered as committed required. + Experience in GxP systems, Computer System Validation , and consistent track record in the support of ... FDA regulated systems and business required. + Strong interpersonal skills required. Excellent communication, networking, and influencing skills including the… more
- OnKure, Inc. (Boulder, CO)
- …of GxP regulations, Quality Systems (including Document Control, Training, Change Control, computer system validation , 21 CFR Part 11) and relevant regulatory ... Quality Management Systems including management and maintenance Experience with FDA and/or other regulatory agency inspections and inspection readiness activities… more