- 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
- Medtronic (Boulder, CO)
- …qualifications. Responsibilities of this position will include project management, validation procedures, manufacturing job instructions, execution of the ... following and other duties may be assigned. + Develop and execute validation strategy of various changes including scrap reduction, fixture improvements, supplier… more
- Novo Nordisk (Boulder, CO)
- …production. Routine interactions with analytical development for implementation and validation of analytical methods. Essential Functions + Requires full-time, ... FTIR + Work closely with Analytical Development on method validation protocols and execution relevant to product methods +...+ Must demonstrate attention to detail, proofreading & strong computer skills with a willingness to learn new IT… more
- Antech Diagnostics (Westminster, 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)
- …customers (Spine Surgeons) to improve designs. + Understands verification and validation activities, ensuring products meet user needs, system requirements, and ... with technology developments in specialized area + Experience working in an FDA regulated and/or medical device environment with ISO and Quality System Regulation… more
- Cardinal Health (Denver, CO)
- …meetings as scheduled and follow up on improvement actions. + Support process validation and calibration programs and activities for the portfolio. + Manage and ... standards, principles, and techniques utilized within the Quality Assurance field + FDA regulated industry experience as well as applicable Quality System Standards… more
- Medtronic (Lafayette, CO)
- …with technology developments in specialized area + Experience working in an FDA -regulated and/or medical device environment with ISO and Quality System Regulation ... methodologies including requirements development, analysis, allocation, review, tracing, and verification/ validation + Knowledge of manufacturing processes including machining and… more
- Sumitomo Pharma (Denver, CO)
- …programmers on SDTM/ADaM datasets and TLF specifications. + Perform programming validation for key derived datasets and oversee Quality Control (QC) efforts ... Statistics + Good understanding and working knowledge of GCPs, ICH guidelines, FDA and other applicable country regulations + Advanced proficiency in BASE SAS… 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