- 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 . * ... are in compliance with company SOPs, cGMP/cGLP standards and FDA /EU regulations. The Manager of Quality Assurance leads and...controls, and CAPA) in the QMS. * Creates departmental systems that foster a culture of quality and continuous… more
- Medtronic (Lafayette, CO)
- …instruments, and systems , conducting product and use testing, and managing system interfaces. You will actively seek Voice of the Customer (VOC) input and ... evaluations, including numerical verification + Defines and performs verification and validation activities, ensuring products meet user needs, system … 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
- Cognizant (Denver, CO)
- …management and delivery with benefits delivered as committed required. + Experience in GxP systems , Computer System Validation , and consistent track ... responsible for: + Act as subject matter expert on system design and architecture. + Solutioning and designing new...record in the support of FDA regulated systems and business required. +… 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 ... implementation of solutions Proficiency and experience with electronic Quality Management Systems including management and maintenance Experience with FDA and/or… more
- Sumitomo Pharma (Denver, CO)
- …processes, and systems to enable accurate and timely data capture, validation , and reporting + Oversee and directly manage the collection, integration, and ... + Partner with internal and external partners/vendors to implement and/or enhance systems supporting transparency reporting + Serve as the subject matter expert on… more